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Clinical Trial Listing

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
 
2002.938.W - Stroke Prevention with Carotid Stenting vs Carotid Endarterectomy 
This study seeks to contrast the relative effectiveness of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA) in preventing stroke, myocardial infarction, and death during a 30-day peri-procedural period, and stroke ipsilateral to the study artery over the follow-up period in patients with symptomatic and asymptomic extracranial carotid stenosis
 
2003.123.B - Strokes and the effects of Closure of Patent Foramen Ovale 
To determine whether closure of PFO is superior  to medical therapy is subjects who have had a stroke with PFO as the only risk factor.
 
2006.165.B - Parkinson's Disease and the effects of a Dopamine-Agonist Patch 
The study is monitoring the effectiveness of a dopamine-agonist in the form of a 24-hour continuous delivery patch for Parkinson's disease.
 
2006.173.A - Lupus and the effects of Belimumab 
This study is looking to evaluate the safety and effectiveness of Belimumab (LymphoStat-B™) in patients with Systemic Lupus Erthematosus (SLE)
 
2007.004.A - Parkinson's and the effects of Creatine 
To evaluate creatine as a potential neuroprotective substance
 
2008.104.C - Parkinson's (new onset) and the effects of CoQ10 
Purpose - To Find a Neuro-Protective Drug
 
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.


 
2008.130.A - Fibromyalgia, Depression, and Anxiety and the effects of Computerized Cognitive Behavioral Therapy 
To see if the use of a computer program for cognitive behavior therapy helps to relieve symptoms of depression and anxiety in patients with fibromyalgia.
 
2008.154.A - A Registry for Patients with Fibromuscular Dysplasia 
Gather a wide variety of information related to patients with Fibromuscular Dysplasia (FMD).
 
2008.165.A - CRT and the effects of OPTIMISE 
Demonstrate that the QuickOpt method provides simple, practical method to enhance clinical response to CRT.
 
2009.075.C - Heart Attacks and the effects of Vest Prevention of Early Sudden Death Trial (VEST) 
To determine if wearing an automatic defibrillator vest will reduce sudden death mortality in the first 90 days following a heart attack in people with an ejection fraction <35%
 
2009.097.A - Idiopathic Parkinson's Disease and the effects of Inosine 
To evaluate safety, tolerability and neuroprotective potential of the drug Inosine.
 
2010.035.B - Heart Failure Therapy and the effects of Left Atrial Pressure Monitoring 
To evaluate the safety and effectiveness of the Left Atrial Pressure Monitoring Systems.
 
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

 

 

 
2010.092.A - Epilepsy and the effects of Intravenous Carbamazepine as short-term replacement of Oral Carbamazepine 
To assess the safety and tolerability of intravenous (IV) carbamazepine (CBZ)
 
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.


 
2010.190.B Relapsing Multiple Sclerosis and the effects of JCV antibodies while on or considering Tysabri. 
The purpose of STRATIFY-2 is to better understand whether antibodies to JCV may be used to predict whether a patient is at higher or lower risk for developing PML.
 
2011.001.A - Heart Failure and the effects of the Optimizer Heart Failure Device 
To evalute the effectivenes and safety of the Optimizer device in heart failure patients.
 
2011.034.A - Arrhythmia/ Atrial Flutter and the evaluation of saftey and performance of Catheter Robotics (Amigo) in mapping the heart 
To test the ability of a new device that may be used to help put the catheters in place in the heart to record exactly where your arrhythmia is coming from in your heart
 
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
 
2012.014.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.


 
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.
 
2012.051.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.
 
2012.093.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.


 
2012.118.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.
 
2012.134.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.
 
2012.171.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
 
2012.209.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.


 
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.
 
2013.054.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.
 
2013.091.A - Chemotherapy Induced Nausea in Children and the Effects of Acupressure 

OBJECTIVES:

Primary

  • To compare the control of chemotherapy-induced nausea (CIN) in the acute phase provided by a 5-HT3 antagonist combined with acupressure versus placebo acupressure in children 4 to 18 years of age being treated with chemotherapy including cisplatin ≥ 50 mg/m2/dose, ifosfamide plus etoposide/doxorubicin, or cyclophosphamide plus an anthracycline.

Secondary

  • To compare the control of CIN in the delayed phase provided by a 5-HT3 antagonist combined with acupressure versus placebo acupressure in children 4 to 18 years of age being treated with chemotherapy including cisplatin ≥ 50 mg/m2/dose, ifosfamide plus etoposide/doxorubicin, or cyclophosphamide plus an anthracycline.
  • To compare the control of chemotherapy-induced vomiting and retching (CIV) in the acute and delayed phases provided by a 5-HT3 antagonist combined with acupressure versus placebo acupressure in children 4 to 18 years of age being treated with chemotherapy including cisplatin ≥ 50 mg/m2/dose, ifosfamide plus etoposide/doxorubicin, or cyclophosphamide plus an anthracycline.

OUTLINE: This is a multicenter study. Patients are stratified according chemotherapy regimen and anti-emetic Regimen 5-HT3 agonists (ondansetron or granisetron.) Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients wear Sea-Band acupressure wristbands on each wrist beginning approximately 30 minutes prior to the first cisplatin-containing chemotherapy course and continually for 24 hours after the last chemotherapy dose (acute phase), and for a maximum of 7 days or until the next chemotherapy course starts (delayed phase). Patients are allowed to take bands off intermittently (up to 4 times a day, for no more than 15 minutes each time) to relieve pressure or to bathe. Patients also receive standard of care anti-emetic prophylaxis comprising granisetron, ondansetron, or dexamethasone during chemotherapy according to institutional or physician preference.
  • Arm II: Patients wear placebo wristbands on each wrist and receive standard of care anti-emetic prophylaxis during chemotherapy as patients in arm I.

Patients, parents, or guardians are instructed to complete an impatient and an outpatient diaries on nausea severity and the time of each emetic episode. Patients, parents, or guardians also complete a questionnaire about acupressure at the end of the study.

 

 
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.

 

 
2013.166.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.

 
2013.221.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.


 
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.


 
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.

 
2014.059.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.


 
2014.153.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.


 
2014.173.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.


 
2014.177.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.
 

 

 
2014.187.N - Non-Rhabdomyosarcome Soft Tissue Sarcomas and the effect of Pazopanib Neoadjuvant 

PRIMARY OBJECTIVES:

I. To identify the dose of pazopanib (pazopanib hydrochloride) that is feasible when given in combination with radiation or chemoradiation in pediatric and adult patients newly diagnosed with unresected intermediate- and high-risk non-rhabdomyosarcoma soft tissue sarcomas (NRSTS).

II. To compare the rates of near complete pathologic response (> 90% necrosis) with the addition of pazopanib to preoperative chemoradiation versus preoperative chemoradiation alone for potentially resectable > 5 cm, grade 3 intermediate to high risk chemotherapy-sensitive NRSTS in the phase II portion of the study for this cohort.

III. To compare the rates of near complete pathologic response (> 90% necrosis) with the addition of pazopanib to preoperative radiotherapy versus preoperative radiotherapy alone for potentially resectable intermediate to high risk adult and pediatric NRSTS in the phase II portion of the study for this cohort (using a phase II decision rule to go onto the Phase III portion of the study).

IV. To compare the rates of event-free survival (EFS) with the addition of pazopanib to preoperative radiotherapy versus preoperative radiotherapy alone for localized intermediate to high risk adult and pediatric NRSTS in the phase III portion of the study for this cohort if the phase II decision rule is passed.

SECONDARY OBJECTIVES:

I. To estimate the rates of local failure, regional failure, distant metastasis free survival, disease-free survival, and overall survival with the addition of pazopanib to preoperative chemoradiation or preoperative radiation in intermediate to high risk adult and pediatric NRSTS.

II. To compare the pattern of recurrence (local, regional and distant) between preoperative chemoradiation or radiation with the addition of pazopanib for adult and pediatric NRSTS.

III. To define the toxicities of ifosfamide and doxorubicin (doxorubicin hydrochloride) chemotherapy and radiation when used in combination with pazopanib in intermediate to high risk adult and pediatric NRSTS.

IV. To define the toxicities of preoperative radiotherapy when used in combination with pazopanib in intermediate to high risk adult and pediatric NRSTS.

TERTIARY OBJECTIVES:

I. To gain insight into the disease biology of childhood and adult NRSTS through analysis of actionable mutations and whole genome sequencing.

II. To determine if microvessel density and circulating tumor deoxyribonucleic acid (DNA) predict response to pazopanib and outcome.

III. To determine the effect of pazopanib on doxorubicin exposure in children and adults with NRSTS.

IV. To evaluate change in fludeoxyglucose F 18 (FDG) positron emission tomography (PET) maximum standard uptake value (SUVmax) from baseline to week 10 or 13 in patients with unresected tumors and to correlate this change with pathologic response and EFS.

V. To compare the rate of response by standard imaging and pathologic assessment to determine which correlates better with local tumor control, distant tumor control, EFS, and overall survival.

OUTLINE: This is a dose-escalation study of pazopanib hydrochloride.

CHEMOTHERAPY COHORT: Patients eligible for chemotherapy cohort are randomized to 1 of 2 treatment regimens.

REGIMEN A:

INDUCTION PHASE: Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on weeks 1-12, ifosfamide intravenously (IV) over 2-4 hours on days 1-3 on weeks 1, 4, 7, 10, and doxorubicin hydrochloride IV over 1-15 minutes on days 1-2 on weeks 1 and 4. Patients undergo radiation therapy on weeks 4-10.

SURGERY: Patients undergo surgery on week 13.

CONTINUATION PHASE: Patients receive pazopanib hydrochloride PO QD on weeks 16-25, ifosfamide IV over 2-4 hours on days 1-3 on weeks 16 and 19, and doxorubicin hydrochloride IV over 1-15 minutes on days 1-2 on weeks 16, 19, and 22. Patients undergo radiation therapy on weeks 16-25 for a total of 45 Gy.

REGIMEN B:

INDUCTION PHASE: Patients receive ifosfamide IV over 2-4 hours on days 1-3 on weeks 1, 4, 7, 10 and doxorubicin hydrochloride IV over 1-15 minutes on days 1-2 on weeks 1 and 4. Patients undergo radiation therapy on weeks 4-10.

SURGERY: Patients undergo surgery on week 13.

CONTINUATION PHASE: Patients receive ifosfamide IV over 2-4 hours on days 1-3 on weeks 16 and 19 and doxorubicin hydrochloride IV over 1-15 minutes on days 1-2 on weeks 16, 19, and 22. Patients undergo radiation therapy on weeks 16-25 for a total of 45 Gy.

NON-CHEMOTHERAPY COHORT: Patients eligible for non-chemotherapy cohort are randomized to 1 of 2 treatment regimens.

REGIMEN C:

INDUCTION PHASE: Patients receive pazopanib hydrochloride PO QD on weeks 1-9. Patients undergo radiation therapy on weeks 1-7.

SURGERY: Patients undergo surgery on week 10.

CONTINUATION PHASE: Patients receive pazopanib hydrochloride PO QD on weeks 13-25. Patients undergo radiation therapy on weeks 13-16 for a total of 50 Gy.

REGIMEN D:

INDUCTION PHASE: Patients undergo radiation therapy on weeks 1-7.

SURGERY: Patients undergo surgery on week 10.

CONTINUATION PHASE: Patients undergo radiation therapy on weeks 13-16 for a total of 50 Gy.

After completion of study treatment, patients are followed up at 6, 12, 18, 24, 30, 36, 48, and 60 months.

 

 
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.

 
2014.263.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.


 
2014.271.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.


 
2015.001.N - Metastatic Ewing Sarcoma and the Effects of Combination Chemotherapy With or Without Ganitumab 

This randomized phase II trial studies how well combination chemotherapy with or without ganitumab works in treating patients with newly diagnosed Ewing sarcoma that has spread to other parts of the body. Monoclonal antibodies, such as ganitumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether combination chemotherapy is more effective with or without ganitumab in treating patients with newly diagnosed Ewing sarcoma.


 
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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