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Clinical Trial Listing

- 2012.014.A - Follicular Lymphoma and the Effects of Combined Rituximab and Lenalidomide Treatment 

The purpose of this study is to evaluate the effect of the combined treatment of lenalidomide and rituximab in controlling the Follicular Lymphoma disease and also increase the length of response compared to the available standard combination chemotherapy treatment for Follicular Lymphoma.

 

 
- 2013.221.B - Diffuse Large B Cell Lymphoma and the Efffects of R2CHOP vs. RCHOP 

This randomized phase II trial studies how well rituximab and combination chemotherapy with or without lenalidomide works in treating patients with newly diagnosed stage II-IV diffuse large B cell lymphoma. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether rituximab and combination chemotherapy are more effective when given with or without lenalidomide in treating patients with diffuse large B cell lymphoma.


 
- 2014.177.N - Castration Resistant Metastatic Prostate Cancer and the Effects of Enzalutamide +/- Abiraterone and Prednisone 

Patients are randomized to one of two treatment groups: enzalutamide or enzalutamide, abiraterone and prednisone. Treatment will continue until disease progression or unacceptable toxicity. Patients are followed for clinical outcomes for a maximum of 5 years post study treatment. The primary and secondary objectives are described below.

  1. Primary Objective:

    To compare the overall survival of patients with progressive metastatic castration-resistant prostate cancer (CRPC) treated with either enzalutamide only or enzalutamide with abiraterone (abiraterone acetate) and prednisone

  2. Secondary Objectives:

    • To assess the grade 3 or higher toxicity profile and compare safety by treatment arm.
    • To assess and compare post-treatment prostate-specific antigen (PSA) declines by treatment arm.
    • To compare radiographic progression free survival defined by Prostate Cancer Working Group 2 (PCWG2), and objective response rate, by treatment arm.
    • To test for radiographic progression free survival (rPFS) treatment interaction in predicting overall survival.
    • To assess pre- and post-treatment measures of tumor burden and bone activity using sodium fluoride (NaF) positron emission tomography (PET)/computed tomography (CT) and technetium (Tc) methylene diphosphonate (MDP) bone scintigraphy and correlate these measures with overall survival.
    • To develop and validate prognostic and predictive models of overall survival that include baseline clinical and molecular markers.
 

 

 
- 2014.197.N - Recurrent Endometrial Cancer and the Effects of Paclitaxel/Carboplatin +/- Metformin 

PRIMARY OBJECTIVES:

I. To determine if the addition of metformin (metformin hydrochloride) to the standard regimen of carboplatin and paclitaxel prolongs progression-free survival (PFS) in women with advanced or recurrent endometrial cancer. (Phase II) II. To determine if the addition of metformin to the standard regimen of carboplatin and paclitaxel prolongs overall survival (OS) in the same population if a phase III study is conducted. Both clinical trials (Phase II and III) will utilize OS as a primary endpoint if a phase III trial is opened.

SECONDARY OBJECTIVES:

I. To estimate the proportion of patients with objective response (response rate [RR]) in the population of patients with measurable disease by treatment.

II. To estimate the duration of response in the population of patients with measurable disease who respond by treatment.

III. To estimate overall survival (OS) and relative hazards of death for each treatment arm if the study stops after the phase II trial is completed. If the study continues with a phase III clinical trial, then PFS will be a secondary endpoint.

IV. To determine the nature, frequency and degree of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) for each treatment arm.

V. To estimate possible differences in RR, PFS, OS, and toxicity rates for the treatment regimens by the patients' level of obesity.

TERTIARY OBJECTIVES:

I. To explore the association of metabolic factors (i.e. body mass index [BMI], hip-to-waist ratio, diabetes status, hemoglobin A1c [HgbA1C], fasting insulin and glucose levels, homeostatic model assessment [HOMA] scores) with treatment response to metformin/paclitaxel/carboplatin.

II. To correlate expression of the metformin transporter proteins (i.e., organic cation transporters [OCT] 1-3, multidrug and toxin extrusion [MATE] 1/2 and plasma membrane monoamine transporter [PMAT]) and key targets of the metformin/mammalian target of rapamycin (mTOR) signaling pathway with treatment response to metformin/paclitaxel/carboplatin.

III. To estimate differences in physical functioning, physical activity, and fatigue between treatment arms.

IV. To explore the association between metabolic factors (i.e., BMI, hip-to-waist ratio, diabetes status, HgbA1C, fasting insulin and glucose levels, HOMA scores) and physical functioning, physical activity, and fatigue.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours on day 1, carboplatin IV over 30 minutes on day 1, and metformin hydrochloride orally (PO) twice daily (BID) on days 1-21 (once daily [QD] in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive paclitaxel IV and carboplatin IV as in Arm I. Patients also receive placebo PO BID on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

 
- 2014.218.B - Photodynamic Therapy (PDT) Oncology Registry 
Participating centers will need to describe its own mechanism for patient identification and eligibility screening. A data manager, identified by the Principal Investigator at each participating center, will screen all patients for eligibility. Appointment, diagnosis and treatment data will be reviewed using information such as clinic records, appointment lists, pathology department records, OR schedule and/or tumor registries. Patients meeting inclusion criteria will be enrolled in the 3-year registry which will comprise retrospective and prospective parts. Patients will be accrued retrospectively for the first 12-month period of the registry. The retrospective part will include patients who received PDT with Photofrin® from 2007 up to 2012. Patients who are eligible but die prior to enrollment will also be included to minimize bias resulting from non-inclusion of advanced stage patients. The prospective recruitment parts will be three years. The estimated length of follow-up for each patient will be 3 years. Follow-up will be conducted by research study staff at each institution via medical record review, under the direction of the Principal Investigator at that site. No patients will be contacted at any point to obtain study data or for follow-up.
 
- 2014.221.B: Refractory Colorectal Cancer and the Effects of Nintedanib (BIBF 1120) vs Placebo 

The objective of this Phase III study is to evaluate the efficacy of nintedanib in patients with metastatic colorectal cancer (mCRC) after failure of previous treatment with standard chemotherapy and biological agents.


 
- 2014.256.N - T-Cell ALL or Stage II-IV T-Cell Lymphoblastic Lymphoma and the Effects of Combination Chemotherapy With or Without Bortezomib 

PRIMARY OBJECTIVES:

I. To compare event-free survival (EFS) in patients with newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LLy) who are randomized to a modified augmented Berlin-Frankfurt-Münster (ABFM) backbone versus bortezomib plus the modified ABFM backbone.

SECONDARY OBJECTIVES:

I. To determine the safety and feasibility of modifying standard therapy for T-ALL and T-LLy based on the results of UKALL 2003, which includes a dexamethasone-based induction, additional doses of pegaspargase (PEG-ASP) during induction and delayed intensification (DI), and dexamethasone pulses during maintenance therapy.

II. To determine if prophylactic (presymptomatic) cranial irradiation (CRT) can be safely and effectively eliminated in the 85-90% of T-ALL patients classified as standard or intermediate risk.

III. To determine the proportion of end of consolidation (EOC) minimal residual disease (MRD) >= 0.1% T-ALL patients who become MRD negative (undetectable by flow cytometry) after intensification of chemotherapy, using three high risk (HR) BFM blocks, and to compare EFS between the patients who become MRD negative after the three HR BFM blocks and continue on chemotherapy with those who continue to have detectable MRD and are eligible for other treatment strategies, including hematopoietic stem cell transplant (HSCT). Similarly, to compare the EFS between very high risk (induction failure) T-LLy patients treated with HR BFM intensification blocks who have partial or complete response (PR or CR) with those who do not respond (NR).

TERTIARY OBJECTIVES:

I. To investigate the prognostic significance of day 29 bone marrow (BM) MRD in T-LLy patients.

II. To determine if protein expression patterns can predict bortezomib response and drug resistance in T-ALL.

III. To analyze and target relevant signaling pathways in T-ALL blasts, focusing on early T cell precursor (ETP) acute lymphoblastic leukemia (ALL).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

INDUCTION ARM A: Patients receive cytarabine intrathecally (IT) at time of diagnostic lumbar puncture (if within 72 hours from start of protocol therapy) OR day 1; vincristine sulfate intravenously (IV) on days 1, 8, 15, and 22; dexamethasone orally (PO) twice daily (BID) on days 1-28 (no taper); daunorubicin hydrochloride IV over 1-15 minutes on days 1, 8, 15, and 22; pegaspargase IV over 1-2 hours on days 4 and 18; and methotrexate IT on days 8 and 29 (and on days 15 and 22 for central nervous system 3 involvement [CNS3] T-ALL patients).

INDUCTION ARM B: Patients receive bortezomib IV on days 1, 4, 8, and 11; and vincristine sulfate, dexamethasone, daunorubicin hydrochloride, pegaspargase, and methotrexate as in Induction Arm A.

CONSOLIDATION: Beginning on day 36 from Induction, patients receive methotrexate IT on days 1, 8, 15, and 22 (days 1 and 8 only for CNS3 T-ALL or CNS3 T-LLy patients); cyclophosphamide IV over 30-60 minutes on days 1 and 29; cytarabine IV over 1-30 minutes or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39; mercaptopurine PO once daily (QD) on days 1-14 and 29-42; pegaspargase IV over 1-2 hours on days 15 and 43; and vincristine sulfate IV on days 15, 22, 43, and 50. Patients with persistent testicular disease undergo radiation therapy.

Patients are then assigned to subsequent therapy according to risk assignment. Patients with standard risk (SR) disease receive Interim Maintenance with Capizzi methotrexate (CMTX); patients with intermediate risk (IR) disease receive Interim Maintenance with high-dose methotrexate (HDMTX), Delayed Intensification, and then Interim Maintenance with CMTX; and patients with very high risk (VHR) disease receive 3 HR Intensification Blocks, Delayed Intensification, and then Interim Maintenance with CMTX.

CMTX INTERIM MAINTENANCE: Patients receive vincristine sulfate IV on days 1, 11, 21, 31, and 41; methotrexate IV over 2-5 minutes (undiluted) or 10-15 minutes (diluted) on days 1, 11, 21, 31, and 41; pegaspargase IV over 1-2 hours on days 2 and 22; and methotrexate IT on days 1 and 31. The next course (based on risk assignment) begins on day 57 or when blood counts recover (whichever occurs later).

DELAYED INTENSIFICATION ARM A: Patients receive vincristine sulfate IV on days 1, 8, 15, 43, and 50; dexamethasone PO BID or IV on days 1-7 and 15-21; doxorubicin hydrochloride IV over 15 minutes on days, 1, 8, and 15; pegaspargase IV over 1-2 hours on days 4, 18, and 50; methotrexate IT on days 1, 29, and 36; cyclophosphamide IV over 30-60 minutes on day 29; cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39; and thioguanine PO on days 29-42. The next course (based on risk assignment) begins on day 64 or when blood counts recover (whichever occurs later).

DELAYED INTENSIFICATION ARM B: Patients receive bortezomib IV on days 1, 4, 15, and 18; and vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, methotrexate, cyclophosphamide, cytarabine, and thioguanine as in Delayed Intensification Arm A. The next course (based on risk assignment) begins on day 64 or when blood counts recover (whichever occurs later).

HDMTX INTERIM MAINTENANCE: Patients receive high-dose methotrexate IV over 24 hours on days 1, 15, 29, and 43; leucovorin calcium IV or PO on days 3-4, 17-18, 31-32, and 45-46; vincristine sulfate IV on days 1, 15, 29, and 43; mercaptopurine PO QD on days 1-56; and methotrexate IT on days 1-29. The next course (based on randomization assignment) begins on day 57 or when blood counts recover (whichever occurs later).

INTENSIFICATION BLOCK I: Patients receive dexamethasone IV or PO BID on days 1-5; high-dose methotrexate IV over 24 hours on day 1; leucovorin calcium IV or PO on days 3-4; vincristine sulfate IV on days 1 and 6; cyclophosphamide IV over 1-6 hours on days 2-4; high-dose cytarabine IV over 3 hours every 12 hours on day 5; pegaspargase IV over 1-2 hours on day 6; and triple IT therapy comprising methotrexate IT, hydrocortisone IT, and cytarabine IT on day 1. The next course (Intensification Block II) begins on day 22 or when blood counts recover (whichever occurs later).

INTENSIFICATION BLOCK II: Patients receive dexamethasone PO BID or IV on days 1-5; high-dose methotrexate IV over 24 hours on day 1; leucovorin PO or IV on days 3-4; vincristine sulfate IV on days 1 and 6; ifosfamide IV over 1 hour every 12 hours on days 2-4; daunorubicin IV over 30 minutes on day 5; pegaspargase IV over 1-2 hours on day 6; and triple IT therapy on day 1 as in Intensification Block I. The next course (Intensification Block III) begins on day 22 or when blood counts recover (whichever occurs later).

INTENSIFICATION BLOCK III: Patients receive dexamethasone PO BID or IV on days 1-5; high-dose cytarabine IV over 3 hours every 12 hours on days 1-2; etoposide IV over 1-2 hours every 12 hours on days 3-5; pegaspargase IV over 1-2 hours on day 6; and triple IT therapy on day 5 as in Intensification Block I. The next course (based on randomization) begins on day 22 or when blood counts recover (whichever occurs later).

MAINTENANCE THERAPY: All patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID or IV on days 1-5, 29-33, and 57-61; mercaptopurine PO on days 1-84; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 (omit day 29 for SR patients during the first 4 courses); methotrexate IT on day 1 (and day 29 during the first 4 courses for SR patients and during the first 2 courses for IR patients). Patients with CNS3 IR disease also undergo cranial radiation therapy during the first 4 weeks (course 1). Treatment in female patients with T-ALL and patients with T-LLY repeats every 12 weeks for up to 2 years from the start of Interim Maintenance (week 119). Treatment in male patients with T-ALL repeats every 12 weeks for up to 3 years from the start of Interim Maintenance (week 171).

All treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically for up to 10 years.

 
- 2014.271.A - Non-Squamous, Non-Small Cell Lung Cancer and the Effects of Pemetrexed +/- TH-302 

The purpose of this study is to determine whether TH-302 in combination with pemetrexed is safe and effective in the treatment of non-squamous non-small cell lung cancer.


 
- 2014.299.A: KRAS-Wildtype, Irinotecan-Refractory, Metastatic Colorectal Cancer and the Effects of Irinotecan, Cetuximab, and Bevacizumab vs. Placebo 

The purpose of this research study is to see if cancer will respond better to a combination of irinotecan and cetuximab with or without bevacizumab


 
001: FOR MORE INFORMATION ON ANY OF THESE TRIALS PLEASE CALL 504-842-4481 
Call 504-842-4481 to reach the main line for the Ochsner Cancer Institute Clinical Trials Department. Leave a message with a summary of your diagnosis and/or trial interests and we will call you back as soon as possible
 
2008.124.N - Rectal Cancer and the effects of Laparoscopic-Assisted vs Open Resection 
This randomized phase III trial is studying laparoscopic-assisted resection to see how well it works compared with open resection in treating patients with stage IIA, stage IIIA, or stage IIIB rectal cancer.
 
2008.127.N - Stage 1 Non-Small Cell Lung Cancer and the Effects of Different Types of Surgery 

Wedge resection or segmentectomy may be less invasive types of surgery than lobectomy for non-small cell lung cancer and may have fewer side effects and improve recovery. It is not yet known whether wedge resection or segmentectomy are more effective than lobectomy in treating stage IA non-small cell lung cancer. This randomized phase III trial is studying different types of surgery to compare how well they work in treating patients with stage IA non-small cell lung cancer.


 
2010.011.N - Prostate Cancer and the effects of Radiation Therapy with or without Androgen-Deprivation Therapy 
This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with androgen-deprivation therapy in treating patients with prostate cancer.
 
2010.084.N - Pancreas and the effects of Erlotinib and Chemoradiation 
This randomized phase III trial is studying gemcitabine hydrochloride and erlotinib hydrochloride to see how well they work compared with gemcitabine hydrochloride alone followed by the same chemotherapy regimen with or without radiation therapy and capecitabine or fluorouracil in treating patients with pancreatic cancer that was removed by surgery.
 
2010.084.N - Pancreatic Cancer and the Effects of Both Erlotinib and Chemoradiation as Adjuvant Treatment After Resection 

This randomized phase III trial is studying gemcitabine hydrochloride and erlotinib hydrochloride to see how well they work compared with gemcitabine hydrochloride alone followed by the same chemotherapy regimen with or without radiation therapy and capecitabine or fluorouracil in treating patients with pancreatic cancer that was removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Giving chemotherapy together with or without erlotinib hydrochloride and/or radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective when given with or without erlotinib hydrochloride and/or radiation therapy in treating pancreatic cancer

 

 

 
2010.096.N - Liver Cancer and the effects of Sorafenib Tosylate and Doxorubicin Hydrochloride 
Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving sorafenib tosylate together with doxorubicin hydrochloride is more effective than sorafenib tosylate alone in treating liver cancer.
 
2010.154.N - Lung Cancer and the effects of Carboplatin and Paclitaxel with or without Bevacizumab and/or Cetuximab 
This randomized phase III trial is studying carboplatin and paclitaxel to compare how well they work with or without bevacizumab and/or cetuximab in treating patients with stage IV or recurrent non-small cell lung cancer.
 
2010.156.N - Colon Cancer and the effects of Celecoxib 
This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium, and fluorouracil together to compare how well they work when given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery.
 
2010.170.N - Lung Cancer (NSCLC) and the effects of Bevacizumab or Pemetrexed Disodium with Induction Therapy 
This randomized phase III trial is studying bevacizumab and pemetrexed disodium alone or in combination after induction therapy to see how well they work in treating patients with advanced non-squamous non-small cell lung cancer.
 
2010.172.N - Small-Cell Lung Cancer Receiving and the Effects of Radiation Therapy Regimens 

This randomized phase III trial is comparing three different chest radiation therapy regimens to see how well they work in treating patients with limited-stage small cell lung cancer.


 
2011.053.N-Asymptomatic High-Risk Smoldering Multiple Myeloma and the Effects of Lenalidomide vs. Observation Only 

Randomized Phase III Trial of Lenalidomide Versus Observation Alone in Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma Charles Wendling MD 2011.053.N Open to new patients 3 This phase II/III trial is studying lenalidomide to see how well it works compared to observation in treating p

 
2011.113.N - High-Risk Stage III or Stage IV Melanoma and the effects of Ipilimumab or High-Dose Interferon Alfa-2b 
 This phase III clinical trial is studying ipilimumab or high-dose interferon alfa-2b in treating patients with high-risk stage III or stage IV melanoma that has been removed by surgery.
 
2011.188.N - S1007- Invasive Breast Cancer and the effects of Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane 
A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients With 1-3 Positive Nodes, Hormone Receptor-Positive and Her2-Negative Breast Cancer With Recurrence Score (RS) of 25 or Less Greg Bizette, M.D. 2011.188.N Open to new patients 3 This phase III clinical tr
 
2012.015.N - Oropharynx Cancer and the Effects of Radiotherapy Plus Cetuximab vs. Chemoradiotherapy (RTOG 1016) 

Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective with cisplatin or cetuximab in treating oropharyngeal cancer. This phase III trial is studying radiation therapy with cisplatin or cetuximab to see how well it works in treating patients with oropharyngeal cancer.


 
2012.021.N - Protocol for the Enrollment on the Official COG Registry 
The Children's Oncology Group (COG) has established a research network, known as the Childhood Cancer Research Network (CCRN), for collecting information about children & young adults with cancer and other conditions that are characterized by abnormal cell growth but are benign (not cancer) in order to help doctors and scientists better understand childhood cancer. The goal is to have clinical information about every child & young adult diagnosed with cancer and other conditions that are characterized by abnormal cell growth in the United States and Canada. This information can then be used by researchers to answer questions such as whether childhood cancer is increasing across the United States or Canada, and whether there is a higher risk of cancer among some groups compared to others. The information can also help researchers study the causes of childhood cancer.
 
2012.022.N - Collecting and Storing Samples of Blood and Tumor Tissue From Patients With Osteosarcoma 

 AOST06B1-A Children's Oncology Group Protocol for Collecting and Banking Osteosarcoma Specimens Rajasekharan Warrier, M.D. 2012.022.N Open to new patients Not Applicable The purpose of this study is to collect and store samples of blood and tumor tissue from patients with osteosarcoma. DISEASE

 
2012.024.N - Collecting and Storing Biological Samples From Patients With Ewing Sarcoma 
This research study is collecting and storing samples of tumor tissue, bone marrow, and blood from patients with Ewing sarcoma.
 
2012.026.N - Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia 
AALL08B1- Classification of Newly Diagnosed Acute Lymphoblastic Leukemia Rajasekharan Warrier, M.D. 2012.026.N Open to new patients Not Applicable This research study is developing a risk-based classification system for patients with newly diagnosed acute lymphoblastic leukemia. DISEASE CHARACTERISTICS:
 
2012.030.B - Advanced Colorectal Cancer and the Effects of Irinotecan Hydrochloride and Cetuximab With or Without Ramucirumab 

RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab and ramucirumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab and ramucirumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. It is not yet know whether giving cetuximab and irinotecan hydrochloride together is more effective with or without ramucirumab in treating colorectal cancer.

PURPOSE: This randomized phase II trial is studying the side effects and how well giving cetuximab and irinotecan hydrochloride with or without ramucirumab work in treating patients with advanced colorectal cancer with progressive disease after treatment with bevacizumab-containing chemotherapy.


 
2012.042.N - Study of Kidney Tumors in Young Patients 

This laboratory study is looking at kidney tumors in young patients. Collecting and storing samples of tumor tissue, blood, and urine from patients with cancer to study in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer. It may also help the study of cancer in the future.

 
2012.042.N - Study of Kidney Tumors in Young Patients(1) 
This laboratory study is looking at kidney tumors in young patients.
 
2012.051.N - Nonmetastatic Extracranial Ewing Sarcoma and the Effects of Combination Chemotherapy 
This randomized phase III trial is studying combination chemotherapy in treating patients with non-metastatic extracranial Ewing sarcoma.
 
2012.086.N - Lymphoblastic Leukemia and the effects of Risk-Adapted Chemotherapy 
This partially randomized phase III clinical trial is studying different combinations of risk-adapted chemotherapy regimens and their side effects and comparing how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia.
 
2012.087.N - T-Cell ALL/Lymphoblastic Lymphoma Combination Chemotherapy 

This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.

 
2012.090.N - Endometrial Carcinoma and the Effects of Carboplatin and Paclitaxel 
This randomized phase III trial is studying carboplatin and paclitaxel to see how well they work when given with or without cisplatin and radiation therapy in treating patients with stage I, stage II, stage III, or stage IVA endometrial cancer.
 
2012.091.N - Ovarian Cancer and the Effects of Paclitaxel and Carboplatin 
This randomized phase III trial is studying giving paclitaxel together with carboplatin to see how well it works compared with giving paclitaxel together with ifosfamide in treating patients with newly diagnosed persistent or recurrent uterine or ovarian cancer.
 
2012.093.N - Esophageal Cancer and the Effects of Traztuxumab to treatment for HER2-Overexpressing Tmors 
This randomized phase III trial is studying how well giving radiation therapy, paclitaxel, and carboplatin together with or without trastuzumab works in treating patients with esophageal cancer.
 
2012.103.A - Arthralgia induced by AIs and the Effects of Subcutaneous Testosterone 

Testosterone may help relieve moderate or severe arthralgia associated with the use of aromatase inhibitors, such as anastrozole or letrozole. This randomized phase III trial studies testosterone to see how well it works compared to placebo in treating postmenopausal patients with arthralgia caused by anastrozole or letrozole.


 
2012.115.N - Cervical Cancer and the Effects of Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel 
This randomized phase III trial studies how well giving cisplatin and radiation therapy together with or without carboplatin and paclitaxel works in treating patients with locally advanced cervical cancer.
 
2012.118.N - Rectal Cancer and The Effects of Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients Undergoing Surgery 

Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether chemotherapy alone is more effective then chemotherapy plus radiation therapy in treating rectal cancer. This randomized phase II/III trial studies how well chemotherapy alone compared to chemotherapy plus radiation therapy works in treating patients with rectal cancer undergoing surgery

 

 
2012.120.B - Mesothelioma and the Effects of Pemetrexed Disodium vs. Observation After First Line Therapy 
This randomized phase II trial is studying how well pemetrexed disodium or observation works in treating patients with malignant pleural mesothelioma without progressive disease after first-line chemotherapy.
 
2012.128.N - de Novo AML With or Without mutations and the Effects of Bortezomib and Sorafenib Tosylate 
This randomized phase II/III trial is studying how well giving bortezomib and sorafenib tosylate together works in treating patients with newly diagnosed acute myeloid leukemia with or without mutations. Bortezomib and sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
 
2012.129.N - B-precursor ALL and the Effectts of Clofarabine in the Very High Risk Stratum 
This randomized phase III trial is studying how well combination chemotherapy works in treating young patients with newly diagnosed high-risk acute lymphoblastic leukemia.
 
2012.134.N - Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma 
This laboratory study is looking at biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma
 
2012.168.N - Collecting and Storing Tissue for Young Patients With Cancer 
This laboratory study is collecting and storing tissue, blood, and bone marrow samples from young patients with cancer.
 
2012.169.N - AML and the Effects of Caspofungin Acetate or Fluconazole in Preventing Invasive Fungal Infections in Patients 
This randomized phase III clinical trial is studying caspofungin acetate to see how it works compared to fluconazole in preventing invasive fungal infections in patients with acute myeloid leukemia who are undergoing chemotherapy.
 
2012.170.N - Pediatric ALL and Compliance With Mercaptopurine Treatment 
This randomized clinical trial is assessing compliance to a mercaptopurine treatment intervention compared to standard of care in younger patients with acute lymphoblastic leukemia in remission.
 
2012.171.N - Collecting and Storing Tissue, Blood, and Bone Marrow Samples From Patients With Rhabdomyosarcoma or Other Soft Tissue Sarcoma 

The purpose of this study is to collect and store tumor tissue, blood, and bone marrow samples from patients with soft tissue sarcoma that will be tested in the laboratory. Collecting and storing samples of tumor tissue, blood, and bone marrow from patients to test in the laboratory may help the study of cancer.


 
2012.186.N - AML or Stem Cell Transplant Patients and the Effects of Levofloxacin in Preventing Infection 
This randomized phase III trial studies how well levofloxacin works in preventing infection in young patients with acute leukemia receiving chemotherapy or undergoing stem cell transplant. Giving antibiotics may be effective in preventing or controlling early infection in patients receiving chemotherapy or undergoing stem cell transplant for acute leukemia
 
2012.187.N - Collecting and Storing Tissue Samples From Patients With Rare or Cutaneous Non-Hodgkin Lymphoma 
This research study is collecting and storing tissue samples from patients with rare or cutaneous non-Hodgkin lymphoma
 
2012.209.A - Metastatic HER2-, Hormone + Breast Cancer and the Effects of BKM120 With Fulvestrant (BELLE3) 

This study will evaluate whether the addition of daily BKM120 to fulvestrant is effective and safe in treating patients with HR+, HER2-, AI treated locally advanced or metastatic breast cancer who progressed on or after mTor inhibitor based treatment.


 
2012.214.N - Hepatoblastoma and the Effects of Combination Chemotherapy 
This phase III trial is studying the side effects of giving doxorubicin hydrochloride together with combination chemotherapy and to compare different chemotherapy regimens to see how well they work in treating young patients with newly diagnosed liver cancer.
 
2012.215.N - B-cell NHL, B-AL, or Mature B-Cell Leukemia and the Effects of Combination Chemotherapy With or Without Rituximab 

This randomized phase II/III trial studies how well giving combination chemotherapy with or without rituximab works in treating younger patients with stage III or stage IV non-Hodgkin lymphoma or B-cell acute leukemia.  

 
2013.025.N-AML and the effects of Clofarabine as Induction therapy vs. Standard of Care 
This randomized phase III trial is studying clofarabine to see how well it works compared with daunorubicin hydrochloride and cytarabine when followed by decitabine or observation in treating older patients with newly diagnosed acute myeloid leukemia.
 
2013.026.B - Collecting Tissue Samples From Patients With Leukemia or Other Blood Disorders Planning to Enroll in an ECOG Leukemia Treatment Clinical Trial 

Patients submit bone marrow and/or blood samples. The samples are studied to determine patients' eligibility for ECOG leukemia treatment clinical trials. Samples may be stored for future correlative studies related to ECOG treatment clinical trials.

 

 
2013.031.B - Mantle Cell Lymphoma and the Effects of Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide 
This randomized phase II trial studies rituximab, bortezomib, bendamustine, and lenalidomide in treating previously untreated older patients with mantle cell lymphoma.
 
2013.034.C - Follicular Lymphoma and the Effects of Bendamustine Hydrochloride and Rituximab With or Without Bortezomib Followed by Rituximab +/- Lenalidomide 
This randomized phase II trial is studying giving bendamustine hydrochloride and rituximab together with or without bortezomib followed by rituximab with or without lenalidomide to see how well they work in treating patients with high-risk stage II, stage III, or stage IV follicular lymphoma.
 
2013.042.C - Endometrial and Cervical Cancer and the Effect of Standard Versus Intensity-Modulated Pelvic Radiation Therapy 
This randomized phase III trial is studying two different methods of radiation and their side effects and comparing how well they work in treating endometrial and cervical cancer after surgery.
 
2013.054.A - Collecting and Storing Blood and Brain Tumor Tissue Samples From Children With Brain Tumors 
The purpose of this study is to collect and store brain tissue samples and blood from children with brain cancer that will be tested in the laboratory.
 
2013.070.A - Melanoma and the Effect of Ipilimumab With or Without High-Dose Recombinant Interferon Alfa-2b 

This randomized phase II trial studies how well ipilimumab with or without high-dose recombinant interferon alpha-2b works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Recombinant interferon alfa-2b may interfere with the growth of tumor cells. It is not yet known whether ipilimumab is more effective with or without high-dose recombinant interferon alfa-2b in treating melanoma


 
2013.091.A - Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy 
This randomized phase III trial is studying how well acupressure wristbands work with or without standard care in controlling nausea in young patients receiving highly emetogenic chemotherapy.
 
2013.103.N - Early Stage Breast Cancer and the Effects of Standard vs. Comprehensive Radiation after Neoadjuvant Chemotherapy and Surgery 

This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer


 
2013.115.N - Breast Cancer and the effects of primary tumor surgery on Stage IV disease 
This randomized phase III trial is studying early surgery to see how well it works compared to standard palliative therapy in treating patients with stage IV breast cancer.
 
2013.146.B - Carcinoid Tumors and the Effects of Pazopanib vs. Placebo 

This randomized phase II trial studies how well pazopanib hydrochloride works in treating patients with progressive carcinoid tumors. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


 
2013.147.B - Pancreatic Neuroendocrine tumor and the effects of Temozolomide With or Without Capecitabine 

This randomized phase II trial studies how well giving temozolomide with or without capecitabine works in treating patients with advanced pancreatic neuroendocrine tumors. Drugs used in chemotherapy, such as temozolomide and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether temozolomide is more effective with or without capecitabine in treating patients with advanced pancreatic neuroendocrine tumors.


 
2013.157.C - Preventing Recurrence of High Risk Adenomas and the Effects of Eflornithine and Sulindac 

The purpose of this study is to assess whether eflornithine 500 mg or sulindac 150 mg are effective in reducing the 3-year event rate of high risk adenoma or second primary colorectal cancer in Stage 0, I II and III colon cancer patients. The primary hypothesis will test the main effect of each agent, as well as the comparison of placebo alone to the combination of sulindac and eflornithine.

 

 
2013.162.N - Prostate Cancer and the Effects of Androgen-Deprivation Therapy and Radiation Therapy 

Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer.


 
2013.166.N - Stage III-IV Squamous Cell Head and Neck Cancer and the Effects of Radiation Therapy With Cisplatin, Docetaxel, or Cetuximab After Surgery 

Randomized Phase II/III Trial of Surgery and Postoperative Radiation Delivered With Concurrent Cisplatin Versus Docetaxel Versus Docetaxel and Cetuximab for High-Risk Squamous Cell Cancer of the Head and Neck Troy Scroggins, MD 2013.166.N Open to new patients 3 This randomized phase II/III trial studie

 
2013.175.B - Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Cancer and the Effects of Combination Chemo 

 Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, irinotecan hydrochloride, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective in treating tumor cells. This randomized phase II trial studies how well oxaliplatin, leucovorin calcium, and fluorouracil work compared to irinotecan hydrochloride and docetaxel in treating patients with esophageal cancer, gastric cancer, or gastroesophageal junction cancer

 

 
2013.175.B - Advanced/Metastatic Esophageal, Gastric, or GEJ Cancer and the Effects of Treatment Based on ERCC1 (S1201) 
Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, irinotecan hydrochloride, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective in treating tumor cells.  This randomized phase II trial studies how well oxaliplatin, leucovorin calcium, and fluorouracil work compared to irinotecan hydrochloride and docetaxel in treating patients with esophageal cancer, gastric cancer, or gastroesophageal junction cancer.
 
2013.178.A - Stage I-III Breast Cancer and Detecting Genetic Predictors for Musculoskeletal Symptoms Cause by Anastrozole 
This pilot clinical trial studies anastrozole in treating aromatase inhibitor musculoskeletal symptoms in female patients with stage I-III breast cancer. Anastrozole may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
 
2013.185.B - Diffuse Large B Cell Lymphoma and the Effects of Ibrutinib in Combination wtih R-CHOP 

Study IPI-145-08 is an international, multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study designed to evaluate the efficacy and safety of IPI-145 in combination with rituximab vs placebo in combination with rituximab in subjects with previously treated CD20-positive follicular lymphoma.

Approximately 400 subjects will receive 25 mg of IPI-145 or placebo, orally BID for 28 day continuous cycles, in combination with 375 mg/m2 of Rituximab given once weekly for 4 weeks during Cycle 1 and then once on Day 1 of Cycles 4, 6, 8, and 10. Patients will remain on treatment for up to 27 cycles and may continue treatment if clinical benefit is observed.

 
2013.200.A - Ovarian Cancer and the Effects of Screening Using Gynecologic Fluids and Mucus 

Ovarian cancer is deadly and generally diagnosed at late stage when the chances of survival are low. There is a current belief that this cancer starts in the fallopian tubes and progresses towards the ovaries, spreading to the cells on the surface. Within the fallopian tubes and the uterus, there is a constant flow of mucus which has only one exit through the cervix and out the vagina. Proteins that are generated within the entire female reproductive system are trapped into this viscous fluid and eventually released as waste. When a routine PAP test is performed, a sample of this mucus is collected along with any cells, and preserved in the PAP fluid. The fluid is currently discarded but contains a protein profile showing of the status of the cells in the female reproductive system. We have examined this fluid and found that it contains unique peptides/proteins that provide a diagnosis of ovarian cancer when compared against healthy controls. These markers will be initially refined using the comparison of ovarian cancer patients against those with benign adnexal masses that entered the clinic during the same time period.

In this Phase II biomarker validation study we will further refine and validate these biomarkers using a new collection of samples from at least 200 ovarian cancer cases with epithelial ovarian cancer (endometroid and papillary serous histology, most common) and comparing these against 600 patients with a diagnosis of a benign adnexal mass that enter the clinics during the same time period. Patient samples will be collected on their first visit to the gynecologic oncologist at a number of collaborating clinics. Final processing of all of the samples will be performed within the proteomics research facilities of the Mitchell Cancer Institute using Selected Reaction Monitoring (SRM, with mass spectrometry) based on the refined set of makers statistically selected within the first aim. Biomarkers validated within this study will be compared with the well accepted CA-125 data for the patients. The research involves a three year validation and may allow detection of this cancer at a very early stage when the survival is as high as 90%. One aim examines a self-taken test that could allow its use in medically underrepresented and rural areas.


 
2013.207.C - Unresectable Bile Duct and Pancreatic Cancer and the Effects of EndoHPB 

Only a small proportion of patients with biliary obstruction caused by cholangiocarcinoma or pancreatic cancer are suitable for surgical resection. Therefore most patients with malignant biliary obstruction will need palliation of their jaundice to relieve the symptoms of pruritus, malabsorption, sepsis and to minimize potential hepatorenal complications. Restoring biliary flow with relief of jaundice is the primary goal in the palliation of obstructive biliary malignancy. Drainage at endoscopic retrograde cholangiopancreatography (ECRP) is established as a safer approach than at percutaneous transhepatic cholangiography (PTC) because it has a lower risk of bile leak, infection and hemorrhage. ECRP is the first approach to relieve malignant biliary obstruction but sometimes it is not technically possible to stent the patient by this approach, then a PTC needs to be undertaken. Self expanding mesh metal stents (SEMS) were introduced back in the 1990s. Problems can still arise with the use of covered stents such as cholecystitis, pancreatitis or tumor overgrowth at the end of the stent, and not all studies have shown that covered stents actually reduce the problems of tumor ingrowth and consequent stent occlusion. EndoHPB can be deployed via an ERCP or PTC route. By using radiofrequency (RF) energy to heat the tissue in the duct prior to insertion of the stent, the surrounding tissue becomes coagulated and this may may delay tumor growth and the time before the stent lumen becomes blocked. Thereby this allows increased periods between the need for intervention and further stent deployment. If EndoHPB use of luminal RF is demonstrated to be effective in luminal tumor ablation, it may have an additional role as a form of neoadjuvant therapy in cholangiocarcinoma and pancreatic cancer.

 

 
2013.247.N - Hormone-Positive Breast Cancer and the Effects of Everolimus with Endocrine Therapy 

Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer. This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.


 
2013.261.N - Node Positive Breast Cancer and the Effects of Axillary Lymph Node Dissection Vs. Axillary Radiation 

This randomized phase III trial studies axillary lymph node dissection to see how well it works compared to axillary radiation therapy alone in treating patients with node-positive breast cancer previously treated with neoadjuvant chemotherapy followed by surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. This study will evaluate whether radiation therapy is as effective as lymph node dissection.


 
2013.274.C - Esophageal Cancer and the effects of PET Scan-Directed Combined Modality Therapy 

PET scans done during chemotherapy may help doctors assess a patient's response to treatment and help plan the best treatment.

This randomized phase II trial is studying PET scan imaging in assessing response in patients with esophageal cancer receiving combination chemotherapy.

 

 
2014.009.B - Non-hodgkin's Lymphoma and the Effect of GA101 vs. Rituximab 

Patients with previously untreated low tumor burden indolent Non-Hodgkin's Lymphoma (NHL) will receive either rituximab or GA101 weekly for 4 weeks followed by re-staging to determine response.

Rituximab, an anti-CD20 chimeric antibody, was approved by the United States Food and Drug Administration in 1998 for the treatment of patients with relapsed low-grade B-cell lymphomas. Clinically, four weekly doses of rituximab have proven to be well tolerated and effective in previously untreated as well as relapsed patients with low-grade lymphoma.

GA101 is an anti-CD20 humanized and glyco-engineered monoclonal antibody. GA101 has been shown to have increased antibody-dependent cellular cytotoxicity (ADCC) and direct cell-death induction compared to Rituximab. It is possible that GA101 may have greater efficacy than rituximab.

 

 
2014.013.N - Renal Cancer and the Effects of Everolimus after Surgery 

Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. This phase III trial is studying everolimus to see how well it works in treating patients with kidney cancer who have undergone surgery.


 
2014.023.N - Metastatic Hormone Sensitive Prostate Cancer and the Effects of Androgen Deprivation Therapy + Bicalutamide/+ TAK-700 

The purpose of this study is to compare overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide.


 
2014.054.A - Anthracycline Cardiovascular Toxicity and the Effects of Statins 

PRIMARY OBJECTIVES:

Specific Aim 1:

To determine if Atorvastatin(Lipitor) administration preserves LVEF 24 months after initiation of Anthracycline-based adjuvant therapy for adjuvant treatment of breast cancer.

Specific Aim 2:

To determine if baseline to 6-month differences in LVEF predict baseline to 24-month differences in LVEF after Anthracycline-based adjuvant therapy and concomitant atorvastatin therapy.

To achieve these aims, we will perform a double-blind, placebo-controlled, randomized clinical trial of 0 or 40 mg of atorvastatin/day in 250 women scheduled to receive Anthracycline-based adjuvant therapy for treatment of adjuvant breast cancer. We will use innovative noninvasive magnetic resonance imaging (MRI) procedures to accurately measure LVEF. In addition, we will measure LV volumes, myocardial strain, fibrosis, aortic pulse wave velocity (PWV) and wall thickness, all factors that can influence LVEF by altering LV pre-load, after-load, and contractility.19,20 Advanced serum biomarkers will be measured that assess for the presence of oxidative/nitrosative stress, systemic inflammation and circulating neurohormones that also may influence LVEF.

This study will test a new clinical paradigm to manage breast cancer: primary prevention of Anthracycline-based adjuvant therapy-related LV dysfunction using pre-treatment with low-cost statins. In addition, this trial will be the first systematic collection of data regarding the mechanism(s) and time course by which LV dysfunction and subsequent CHF evolve in women given Anthracycline-based adjuvant therapy for adjuvant breast cancer. These data will be useful to physicians trying to determine the optimal cardiac protection strategies when administering adjuvant chemotherapeutic regimens to their breast cancer patients. The objective of this research is to use inexpensive medications to preserve CV health and thereby improve overall survival in the growing number of breast cancer patients.

SECONDARY OBJECTIVES

Specific Aim 1:

To document the effect of Atorvastatin (Lipitor) on cognitive function using a battery of neurocognitive tests (HVLT, Rey-Osterreith Figure, COWA, Trail-making Parts A and B, Digit Span and Grooved Pegboard) in breast cancer patients receiving an anthracycline.

Specific Aim 2:

To document the effect of Atorvastatin(Lipitor) on self-reported quality of life using validated questionnaires (PROMIS including: General form, Cog Concerns, Cog Abilities, Fatigue, Pain intensity and interference, Sleep Disturbance, Physical Functioning and Social Functioning) in breast cancer patients receiving an anthracycline.

 
2014.055.C - Collecting and Banking Pediatric Research Specimens for Rare Pediatric Tumors 

This study is collecting and storing malignant, borderline malignant neoplasms, and related biological samples from young patients with cancer. Collecting and storing samples of tumor tissue, blood, and bone marrow from patients with cancer to study in the laboratory may help the study of cancer in the future.


 
2014.055.C - Collecting and Storing Malignant, Borderline Malignant Neoplasms, and Related Samples From Young Patients With Cancer 

OBJECTIVES:

I. Collect malignant, borderline malignant neoplasms, and related biological specimens from Children's Oncology Group institutions for cases in which there is no disease-specific biologic protocol.

II. Provide a repository for long-term storage of malignant, borderline malignant neoplasms, and related biological specimens from these patients.

III. Make specimens available to qualified researchers to understand the biology of cancer in these patients.

OUTLINE:

Tumor tissue samples, blood, and bone marrow aspirates are collected and stored for future analysis.

 

 
2014.055.C - Rare Pediatric Tumors and the Protocol for Collecting and Banking Research Specimens 

OBJECTIVES:

I. Collect malignant, borderline malignant neoplasms, and related biological specimens from Children's Oncology Group institutions for cases in which there is no disease-specific biologic protocol.

II. Provide a repository for long-term storage of malignant, borderline malignant neoplasms, and related biological specimens from these patients.

III. Make specimens available to qualified researchers to understand the biology of cancer in these patients.

OUTLINE:

Tumor tissue samples, blood, and bone marrow aspirates are collected and stored for future analysis.

 
2014.059.N - Non-Metastatic Desmoplastic Medulloblastoma and the Effects of Combination Chemo for Younger Patients 

This phase II trial studies how well combination chemotherapy works in treating younger patients with newly diagnosed, non-metastatic desmoplastic medulloblastoma. Drugs used in chemotherapy, such as vincristine sulfate, cyclophosphamide, methotrexate, etoposide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.


 
2014.061.A - Metastatic Triple Negative Breast Cancer and the Effects of CDX-011 

The main purpose of this study is to see whether CDX-011 (glembatumumab vedotin, an antibody-drug conjugate) is effective in treating patients who have advanced Triple-Negative Breast Cancer (TNBC; i.e., tumors lacking expression of estrogen, progesterone and HER2 receptors), and whose tumor cells make a protein called glycoprotein NMB (gpNMB), which CDX-011 binds to. The study will also further characterize the safety of CDX-011 treatment in this patient population.


 
2014.070.B - Surgically Resected Pancreatic Adenocarcinoma and the Effects of Nab-Paclitaxel plus Gemcitabine vs. Gemcitabine Alone 

ABI-007-PANC-003 is a Phase 3, international, multicenter, randomized, open-label, controlled study that will compare the efficacy of nab-paclitaxel in combination with gemcitabine to gemcitabine alone as adjuvant treatment for 6 cycles in patients with surgically resected pancreatic adenocarcinoma.

 
2014.079.N - Hormone Receptor, HER2 Positive Breast Cancer and the Effects of Neoadjuvant Therapy with or without Estrogen Deprivation 
This randomized phase III trial studies docetaxel, carboplatin, trastuzumab, and pertuzumab with estrogen deprivation to see how they work compared to docetaxel, carboplatin, trastuzumab, and pertuzumab without estrogen deprivation in treating patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-positive, operable or locally advanced breast cancer.
 
2014.086.A - Locally Recurrent/Metastatic Breast Cancer and the Effects of Eribulin Compared to Standard Weekly Paclitaxel (BOLD 303) 

This is a two arm Phase III trial in first- and second-line HER2 negative patients with locally recurrent or metastatic breast cancer. The primary endpoint is overall survival (OS), and the objective is to test for the superiority of eribulin mesylate over standard weekly paclitaxel. Patients will be randomized between the experimental and control arm with equal allocation (1:1) within strata defined by prior adjuvant taxanes, hormone receptor status, and line of therapy. Subjects will continue protocol directed therapy until documentation of disease progression, development of unacceptable toxicity, or withdrawal of consent. Those who discontinue study treatment without radiological progression will be followed with repeat imaging studies every 12 weeks. All subjects will be followed until death, withdrawal of consent, or study termination.


 
2014.101.C - Relapsed or Refractory Metastatic Colorectal Cancer and the Effects of Ruxolitinib or Placebo in Combination with Regorafinib 

The study consists of an open-label, Part 1 safety run-in (consisting of 1 to 3 cohorts of 9 subjects each), to confirm the safety of the regorafenib/ruxolitinib combination in subjects with relapsed or refractory metastatic colorectal cancer (CRC). If determined to be tolerable, Part 2 will proceed as a randomized, double-blind study evaluating ruxolitinib or placebo in combination with regorafenib in subjects with relapsed or refractory metastatic CRC previously treated with fluoropyrimidine, oxaliplatin, and/or irinotecan based chemotherapy, an anti-vascular endothelial growth factor (VEGF) therapy and if Kirsten rat sarcoma (KRAS) wild type an anti-epidermal growth factor receptor (EGFR) therapy.

Subjects in the safety run-in will receive open-label ruxolitinib and regorafenib; for the randomized, double-blind portion of the study all subjects will receive regorafenib and either ruxolitinib or placebo in a 1:1 blinded manner. Treatment for all subjects will consist of repeating 28-day cycles. Regorafenib will be self-administered for the first 21 days of each cycle, and ruxolitinib/placebo will be self-administered during the entire 28-day cycle. Treatment cycles will continue as long as the regimen is tolerated, and the subject does not meet the discontinuation criteria. When subjects discontinue regorafenib, ruxolitinib or placebo they will remain in the study and be followed for subsequent treatment regimens which are initiated and survival.

 
2014.103.B - Unresectable Advanced Perihilar Cholangiocarcinoma (OPUS) and the Effects of Photodynamic Therapy 

Photodynamic therapy (PDT) is a combination of a drug, porfimer sodium (Photofrin), which is activated by a light from a laser that emits no heat. This technique works to allow the medical doctor to specifically target and destroy abnormal or cancer cells while limiting damage to surrounding healthy tissue. The activation of the drug is done by lighting the abnormal areas using a fiber optic device (very fine fiber like a fishing line that permits light transmission) inserted into a flexible tube with a light called cholangioscope for the bile duct. The light will activate the porfimer sodium concentrated in the abnormal tissue, leading to its destruction.

This research study will evaluate the efficacy and safety of PDT with porfimer sodium administered with Standard Medical Care (SMC) compared to SMC alone on the overall survival time of patients with non-operable advanced cholangiocarcinoma, a rare cancer of the bile ducts. It will involve 200 patients across North America and Europe. Other countries may participate if needed. Participation will last at least 18 months.


 
2014.111.A - Acute Myeloid Leukemia and the Effects of Best Supportive Care +/- Oral Azacitidine 

This is an international, multicenter, placebo-controlled, phase 3 study with a double-blind, randomized, parallel-group design with de novo AML (Acute Myeloid Leukemia) or AML secondary to prior diagnosis of Myelodysplastic Syndromes (MDS).

 
2014.153.N - CLL and the Effects of Bendamustin + Rituximab vs. Ibrutinib + Rituximab vs. Ibrutinib Alone 

This randomized phase III trial studies rituximab with bendamustine hydrochloride or ibrutinib to see how well they work compared to ibrutinib alone in treating older patients with previously untreated chronic lymphocytic leukemia. Monoclonal antibodies, such as rituximab, can block cancer growth in difference ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet know whether rituximab with bendamustine hydrochloride is more effective than rituximab and ibrutinib or ibrutinib alone in treating chronic lymphocytic leukemia.


 
2014.153.N - Untreated CLL Patients and the Effects of Ibrutinib based Therapy vs. Standard Chemoimmunotherapy 

This randomized phase III trial studies ibrutinib and rituximab to see how well they work compared to fludarabine phosphate, cyclophosphamide, and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether fludarabine phosphate, cyclophosphamide, and rituximab are more effective than ibrutinib and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.


 
2014.160.B - Follicular Lymphoma and the Effects of Rituximab +/- IPI-145 

Study IPI-145-08 is an international, multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study designed to evaluate the efficacy and safety of IPI-145 in combination with rituximab vs placebo in combination with rituximab in subjects with previously treated CD20-positive follicular lymphoma.

Approximately 400 subjects will receive 25 mg of IPI-145 or placebo, orally BID for 28 day continuous cycles, in combination with 375 mg/m2 of Rituximab given once weekly for 4 weeks during Cycle 1 and then once on Day 1 of Cycles 4, 6, 8, and 10. Patients will remain on treatment for up to 27 cycles and may continue treatment if clinical benefit is observed.

 
2014.163.A - Gastric and Gastro-Esophageal Junction Cancer and the Effects of BBI608 Plus Weekly Paclitaxel vs. Paclitaxel Alone 

The purpose of this study is to find out whether it is better to receive a new drug, BBI608, in addition to paclitaxel chemotherapy or better to receive paclitaxel chemotherapy alone as second line treatment for gastric and gastroesophageal junction cancer after prior first line platinum and fluoropyrimidine based chemotherapy.


 
2014.171.N - Collecting and Storing Samples of Bone Marrow and Blood From Patients With Relapsed Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma 

OBJECTIVES:

  • Establish a mechanism to bank specimens of tumor cells and host germline DNA from patients with acute lymphoblastic leukemia (ALL) or non-Hodgkin lymphoma at first and subsequent relapse.
  • Make these specimens available to qualified researchers to study the biology of ALL.

OUTLINE: This is a multicenter study.

Patients undergo collection of bone marrow and peripheral blood at diagnosis of relapse and/or at the end of the first month of treatment.

Patients are followed periodically for up to 10 years.

 
2014.173.N - BCR-ABL Negative B Lineage ALL and the Effects of Blinatumomab 

This randomized phase III trial studies combination chemotherapy with blinatumomab to see how well it works compared to induction chemotherapy alone in treating patients with newly diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase (ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as blinatumomab, may block cancer growth in different ways by targeting certain cells. It is not yet known whether combination chemotherapy is more effective with or without blinatumomab in treating newly diagnosed acute lymphoblastic leukemia.


 
2014.176.A - Metastatic Cholangiocarcinoma and the Effects of Nab-Paclitaxel and Gemcitabine 

Patients with advanced or metastatic cholangiocarcinoma (CCA) who are not eligible for curative surgery, transplantation, or ablative therapies will receive nab-paclitaxel and gemcitabine chemotherapy.

The purpose of this study is to evaluate the effectiveness and safety of the combination of nab-paclitaxel and gemcitabine. The effectiveness will be determined by improvement in the length of time during and after treatment, that the CCA does not get worse.


 
2014.192.N - A Biomarker-Driven Master Protocol for Sqamous Cell Lung Cancer 
The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a "non-match" sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.
 
2014.199.B - Advanced Non-Small Cell Lung Cancer and the effects of Abraxane in Combination with Carboplatin 

This is a Phase IV, randomized, open-label, multicenter study of continuous weekly versus weekly times three with one-week break nab-paclitaxel in combination with carboplatin as first-line treatment in elderly subjects (≥ 70 years old) with advanced non small cell lung cancer who have not received prior chemotherapy for their advanced disease and are not candidates for curative surgery or radiation therapy. The primary study endpoint is the percentage of subjects with either peripheral neuropathy or myelosuppression adverse events. Patients will continue treatment until they develop progressive disease, unacceptable side-effects or wish to withdraw from the study, according to local standard of care. Patients will have radiographic evaluations every 6 weeks while on treatment.

 
2014.204.C - Locally Advanced or Metastatic Renal Cell Cancer and the Effects of Cabozatinib with Sunitinib 

PRIMARY OBJECTIVES:

I. To determine if patients with renal cancer treated with cabozantinib (cabozantinib-s-malate) will have improved progression-free survival compared to patients treated with sunitinib (sunitinib malate).

SECONDARY OBJECTIVES:

I. To determine whether the response rate of patients with renal cancer treated with cabozantinib will be higher when compared with patients treated with sunitinib.

II. To determine whether patients with renal cancer treated with cabozantinib will have an improved overall survival when compared with patients treated with sunitinib.

TERTIARY OBJECTIVES:

I. To determine whether renal cancer patients with high met proto-oncogene (MET) expression by immunohistochemistry (IHC) have improvement in progression-free survival compared to patients with low MET expression on both arms of this study.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive cabozantinib-s-malate orally (PO) once daily (QD) for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 5 years.

 
2014.257.N - Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment 

PRIMARY OBJECTIVES:

I. To determine whether patients randomized to the experimental dexrazoxane hydrochloride (DRZ) arms have decreased markers of cardiomyopathy/heart failure (CHF) compared with patients on the standard arm.

II. To evaluate whether the cardioprotective effect of DRZ is modified by anthracycline (anthracycline analogue GPX-150) dose, chest radiation, and demographic factors (age at cancer diagnosis, current age, sex).

SECONDARY OBJECTIVES:

I. To determine whether patients on the DRZ arms experienced differential rates of overall-survival and event-free survival compared with the standard therapy arms.

II. To determine whether projected quality-adjusted life years (QALY) differed by randomization status, accounting for premature cardiac disease, primary disease relapse, and second cancers.

OUTLINE:

Patients complete a diagnostic symptom checklist, undergo a physical exam, echocardiogram, collection of serum for biomarker testing, and a 6 minute walk test, and complete quality of life, family history, physical activity, and smoking questionnaires.

 

 
2014.258.N - Anaplastic Large Cell Lymphoma and the Effects of Brentuximab Vedotin or Crizotinib with Chemotherapy 

PRIMARY OBJECTIVES:

I. To determine the tolerability of brentuximab vedotin given in combination with standard chemotherapy (anaplastic large cell lymphoma [ALCL]99) and to determine the tolerability of crizotinib given in combination with chemotherapy (ALCL99).

II. To estimate the event free survival (EFS) of Arm brentuximab vedotin (BV) and Arm crizotinib (CZ) and contrast these to historical control data.

SECONDARY OBJECTIVES:

I. To determine the prognostic significance of minimal disseminated disease (MDD) at diagnosis and minimal residual disease (MRD) as measured by real-time (RT)-polymerase chain reaction (PCR) in peripheral blood.

OUTLINE: Patients are randomized into 1 of 2 treatment arms.

ARM BV:

COURSE A (COURSES 1, 3, AND 5): Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1, dexamethasone orally (PO) twice daily (BID) or IV on days 1-5, ifosfamide IV over 60 minutes on days 1-5, methotrexate IV over 3 hours on day 1, cytarabine IV over 1 hour every 12 hours for 4 doses on days 4 and 5, and etoposide IV over 2 hours on days 4 and 5.

COURSE B (COURSES 2, 4, AND 6): Patients receive brentuximab vedotin, dexamethasone, and methotrexate as in Arm BV, Course A. Patients also receive cyclophosphamide IV over 30-60 minutes on days 1-5 and doxorubicin hydrochloride IV over 1-15 minutes on days 4 and 5.

ARM CZ:

COURSE A (COURSES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A.

COURSE B (COURSES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B.

In all arms, treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months.

 
2014.263.N - Resected EGFR Mutant Non-Small Cell Lung Cancer and the Effects of Erlotinib vs. Placebo 

This randomized phase III trial studies how well erlotinib hydrochloride compared to placebo works in treating patients with stage IB-IIIA non-small cell lung cancer that has been completely removed by surgery. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


 
2014.264.N - Genetic Screening Study for Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery 

This research trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.


 
2014.265.N - Resected Early Stage Non-Small Cell Lung Cancer and the Effects of Crizotinib vs. Placebo 

This randomized phase III trial studies how well crizotinib works and compares it to placebo in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called ALK. Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Tumors with this mutation may respond to treatments that target the mutation, such as crizotinib. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. It is not yet known if crizotinib may be an effective treatment for treating non-small cell lung cancer with an ALK fusion mutation.


 
2014.266.A - Metastatic Pancreatic Cancer and the Effects of M402 in Combination with Nab-Paclitaxel and Gemcitabine 

Part A was an open-label, multiple ascending dose patient study of necuparanib given first as a single dose and then daily in combination with the nab-paclitaxel and gemcitabine regimen. It was conducted to evaluate the safety and tolerability of necuparanib alone and in combination with nab-paclitaxel and gemcitabine and to recommend a necuparanib dose regimen for subsequent evaluation in Part B. Part B is a randomized, double-blind study investigating the antitumor activity of necuparanib in combination with nab-paclitaxel and gemcitabine compared with nab-paclitaxel, gemcitabine, and placebo. In both Parts A and B, a treatment period consists of one 28-day cycle. The Study Patient and Investigator can decide to continue with additional 28-day cycles according to the patient's status at the end of each 28-day cycle. Part A has completed enrollment and Part B is currently open.

Part A - Primary Objectives:

  • To evaluate the safety and tolerability of necuparanib in combination with nab-paclitaxel and gemcitabine.
  • To determine the dose of necuparanib to be carried forward into Part B.

Part B - Primary Objective:

To evaluate overall survival in patients treated with necuparanib + nab-paclitaxel + gemcitabine compared with placebo + nab-paclitaxel + gemcitabine.

 

 
2014.312.N - High Grade Uterine Leimyosarcoma and the Effects of Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation 

PRIMARY OBJECTIVES:

I. To determine whether overall survival of patients with uterus-limited high-grade leiomyosarcoma is superior among patients assigned to treatment with adjuvant gemcitabine hydrochloride plus docetaxel followed by doxorubicin hydrochloride compared to patients assigned to observation.

SECONDARY OBJECTIVES:

I. To determine whether treatment with adjuvant gemcitabine plus docetaxel followed by doxorubicin improves recurrence-free survival of patients with uterus-limited high-grade leiomyosarcoma compared to observation.

II. To explore the impact of potential predictors of recurrence or death such as patient age, institution-reported tumor size, cervix involvement (yes or no), and mitotic rate. (exploratory)

OUTLINE: This is a multicenter study. Patients are stratified according to country of treating site. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive adjuvant gemcitabine hydrochloride IV over 70-90 minutes on days 1 and 8 and docetaxel IV over 30-60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo computed tomography (CT) and/or magnetic resonance imaging (MRI). Patients with no evidence of disease receive doxorubicin hydrochloride IV every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive filgrastim SC on days 2-8 or pegfilgrastim SC on day 2 or 3.

Arm II: Patients undergo clinical observation.

Patients may undergo tumor tissue sample collection at baseline for future correlative studies.

After completion of study treatment, patients in both arms are followed up every 4 months for 3 years and then every 6 months for 2 years.

 

 
SIGNITURE Module 5: PTCH1 or SMO Mutated Tumors and the Effect of LDE225 

The purpose of this signal seeking study is to determine whether treatment with LDE225 demonstrates sufficient efficacy in hedgehog pathway-mutated solid tumors and/or hematologic malignancies to warrant further study

 

 

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