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A Phase 1b/2 Randomized Study of MEDI-573 in Combination with an Aromatase Inhibitor (AI) versus AI Alone in Women with Metastatic Breast Cancer (MBC)
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This study is being done to find out what effects (good or bad) the combination of the experimental drug MEDI-573 and another kind of anticancer drugs called aromatase inhibitors (AIs) has on you and your breast cancer. As part of this study, researchers would also like to do laboratory testing on tissue samples and blood samples to find out as much as possible about breast cancer and how this treatment might affect the disease.
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Principal Investigator(s):
Corrine Zarwan, MD
For more information about this Research Study call 781-744-8027.
Study Coordinator(s):
Kori D. Hesse.
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A Phase 2 Randomized Open-Label Study of Erlotinib Plus Tivantinib (ARQ 197) Versus Single Agent Chemotherapy in Previously Treated KRAS Mutation Positive Subjects with Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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The purpose of this study is to help test an investigational study drug called tivantinib or ARQ 197 in combination with erlotinib (Tarceva®)
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Principal Investigator(s):
Paul J. Hesketh, MD
For more information about this Research Study call 781-744-8027.
Study Coordinator(s):
Julia C. Roache.
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A Phase II Trial Of NeoAdjuvant Dose-Dense MVAC With Neulasta (Pegfilgrastim) Support In Subjects With Muscle-Invasive Urothelial Carcinoma
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The purpose of this study is to test the effectiveness, safety and side effects of MVAC chemotherapy (methotrexate, vinblastin, adriamycin, cisplatin) with hematologic growth factor support (Neulasta support) for patients with muscle-invasive bladder cancer prior to surgery.
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Principal Investigator(s):
Christopher G. Tretter, MD
For more information about this Research Study call 781-744-8027.
Study Coordinator(s):
Nevin Bhardwaj.
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A Phase III Randomized, Double-Blind, Placebo-Controlled Trial Comparing Capecitabine Plus Sorafenib Versus Capecitabine Plus Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer
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Over the past few years, there has been a huge increase in our knowledge about the important role that hereditary factors (genes) play in the origin and treatment of diseases. Genes are made up of deoxyribonucleic acid (DNA), which is found in your blood cells and tissues. We now have some indication of how the genetic ‘makeup’ of an individual may influence his/her reaction to a specific drug, in terms of both wanted and unwanted effects.
The goal of this Research Study is to identify and analyze genes that are associated with your cancer.
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Principal Investigator(s):
Corrine Zarwan, MD
For more information about this Research Study call 781-744-8027.
Study Coordinator(s):
Kori D. Hesse.
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A Phase III Study Of Chemotherapy And Chemoradiotherapy With Or Without HyperAcute®-Pancreas (algenpantucel-L)Immunotherapy in Subjects With Surgically Resected Pancreatic Cancer
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The purpose of this study is to determine the efficacy of giving subjects with pancreatic cancer the HyperAcute® Pancreas immunotherapy (experimental) along with chemotherapy and chemoradiation (standard). The study immunotherapy is made of two (2) genetically engineered human pancreatic cancer cell types. The purpose of this study is to compare the effects, good and/or bad, of standard of care therapy (gemcitabine alone or with chemoradiation) with or without the addition of HyperAcute®-Pancreas immunotherapy to find out which treatment is better.
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Principal Investigator(s):
Francis W. Nugent, MD
For more information about this Research Study call 781-744-8027.
Study Coordinator(s):
Deborah J. Gannon.
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A Randomized, Double-Blind, Placebo-Controlled Phase III Study To Evaluate The Efficacy And Safety Of Pazopanib As Adjuvant Therapy For Subjects With Localized Or Locally Advanced RCC Following Nephrectomy
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The purpose of this study is to test if the drug pazopanib (also called Votrient®) can prevent or delay the renal cell tumor from coming back after the tumor has been surgically removed. The study will also test the safety of pazopanib.
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Principal Investigator(s):
Christopher G. Tretter, MD
For more information about this Research Study call 781-744-8027.
Study Coordinator(s):
Nevin Bhardwaj.
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A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Monotherapy MORAb-004 Plus Best Supportive Care in Subjects with Chemorefractory Metastatic Colorectal Cancer
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This research is being done to find out if an investigational drug (antibody) called MORAb-004 is safe, well-tolerated, effective in the treatment of metastatic colorectal cancer, how it is used by the body, how your genetics and the study drug work together, and how it impacts your quality of life.
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Principal Investigator(s):
Keith E. Stuart, MD
For more information about this Research Study call 781-744-8027.
Study Coordinator(s):
Kathleen (Kai) Sherman.
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A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Study Of RAD001 Adjuvant Therapy In Poor Risk Patients With Diffuse Large B-Cell Lymphoma (DLBCL) Of RAD001 Versus Matching Placebo After Patients Have Achieved Complete Response With First-Line Rituximab Chemotherapy
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This study is being done to see if giving RAD001 can reduce the chance of relapse when it is given to patients with diffuse large B-cell lymphoma that is in complete remission. Rad001 is currently not approved by the FDA for use in this situation therefore, this treatment is considered experimental.
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Principal Investigator(s):
Tarun Kewalramani, MD
For more information about this Research Study call 781-744-8027.
Study Coordinator(s):
Deborah J. Gannon,
Nancy M. Campbell, RN.
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A Registry of Sipuleucel-T Therapy in Men with Advanced Prostate Cancer
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The purpose(s) of this registry study is to learn more about the occurrence of cerebrovascular events (more commonly known as “strokes”) reported during or following sipuleucel-T therapy, to learn about the survival of all study subjects, to understand the order and timing of anticancer therapies you may receive following treatment with sipuleucel-T, and to look at changes in your prostate specific antigen (PSA) levels following treatment with sipuleucel-T and other anticancer therapies.
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Principal Investigator(s):
Christopher G. Tretter, MD
For more information about this Research Study call 781-744-8027.
Study Coordinator(s):
Nevin Bhardwaj.
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An Open-Label, Randomized, Phase 2 Study to Assess The Effectiveness Of RCHOP With Or Without VELCADE In Previously Untreated Patients With Non-Germinal Center B-Cell-Like Diffuse Large B-Cell Lymphoma
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There are two main categories of DLBCL- 1) germinal center (GC) type and 2) non-GC type. The standard treatment for both types of DLBCL is a combination of drugs called RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). Unfortunately, RCHOP works less well in patients with non-GC DLBCL. However, a better treatment than RCHOP for patients with non-GC DLBCL is not currently known.
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Principal Investigator(s):
Tarun Kewalramani, MD
For more information about this Research Study call 781-744-8027.
Study Coordinator(s):
Deborah J. Gannon,
Nancy M. Campbell, RN.
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CALGB/SWOG C80702: A Phase III Trial Of 6 Versus 12 Treatments Of Adjuvant Folfox Plus Celecoxib Or Placebo For Patients With Resected Stage III Colon Cancer
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This study is being done to evaluate the effects (good and bad) of different chemotherapy treatments. One of the common combinations of chemotherapy drugs used to treat your type of cancer includes 5-fluorouracil (also called 5-FU), leucovorin and oxaliplatin, and is also called “FOLFOX”. At the present time, the Food and Drug Administration (FDA) has approved each of these drugs as treatment for colon cancer. FOLFOX is a standard treatment used to prevent colon cancer from coming back (recurrence).
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Principal Investigator(s):
Keith E. Stuart, MD
For more information about this Research Study call 781-744-8027.
Study Coordinator(s):
Kathleen (Kai) Sherman.
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Collaborative Advanced Stage Tissue Lung Cancer (CASTLE) Network
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To collect, process, store, and distribute tumor-related and normal biospecimens from advanced stage lung cancer patients in support of ALCMI-approved research projects.
To maintain a centralized, computerized database of all specimens with uniform and complete demographic, pathologic, and clinical information.
To facilitate integration of molecular assays and other laboratory studies with demographic data and clinical outcomes.
To obtain funding from National Institutes of Health based on the use of the biorepository to enable or discovery of novel genes and proteins that are being investigated by the academic contributors.
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Principal Investigator(s):
Paul J. Hesketh, MD
For more information about this Research Study call 781-744-8027.
Study Coordinator(s):
Kathleen (Kai) Sherman.
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ECOG 1208: A Phase III, Randomized, Double-Blind Trial of Chemoembolization with or without Sorafenib in Unresectable Hepatocellular Carcinoma (HCC) in Patients with and without Vascular Invasion
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The purpose of this study is to see if adding the oral chemotherapy pill, sorafenib (Nexavar), to localized chemotherapy (chemoembolization) to the liver will help patients to live longer than treatment with localized chemotherapy to the liver without sorafenib. Sorafenib is currently approved by the United States Food and Drug Administration for the treatment of liver cancer and has been shown to inhibit tumor growth. It is not known if the combination of chemoembolization and sorafenib will work better than chemoembolization alone.
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Principal Investigator(s):
Keith E. Stuart, MD
For more information about this Research Study call 781-744-8027.
Study Coordinator(s):
Kathleen (Kai) Sherman.
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ECOG 1609 : A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy versus High-Dose Interferon á-2b for Resected High-Risk Melanoma
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The purpose of this study is to compare the effects, good and/or bad, of ipilimumab with interferon alfa-2b on you and your melanoma to find out which is better. In this study, you will get either ipilimumab or the interferon alfa-2b. You will not get both. We plan to determine whether ipilimumab stops or delays your cancer from returning in comparison to interferon alfa-2b.
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Principal Investigator(s):
Christopher G. Tretter, MD
For more information about this Research Study call 781-744-8027.
Study Coordinator(s):
Nevin Bhardwaj.
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ECOG E1505: A Phase III Randomized Trial Of Adjuvant Chemotherapy With Or Without Bevacizumab For Patients With Completely Resected Stage IB(>= 4cm)-IIIA Non-Small Cell Lung Cancer (NSCLC)
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This research is being done because even with surgery, there is a risk that the lung cancer may recur or spread. Treatment with chemotherapy after surgery has been shown to reduce (but not eliminate) the risk of recurrence or spread. This study is being done to determine whether the addition of a new agent (bevacizumab) to the chemotherapy regimen will further improve the chances of remaining free of lung cancer recurrence or spread. We will compare the effects (good and bad) of adding bevacizumab to chemotherapy with standard chemotherapy alone on you and your lung cancer to see which is better at preventing the cancer from coming back. Bevacizumab is investigational, which means it has not been approved by the FDA for use in this cancer.
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Principal Investigator(s):
Paul J. Hesketh, MD
For more information about this Research Study call 781-744-8027.
Study Coordinator(s):
Julia C. Roache.
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LUX-Lung 8: A Randomized, Open-Label Phase III Trial of Afatinib Versus Erlotinib in Patients with Advanced Squamous Cell Carcinoma of the Lung as Second-Line Therapy Following First-Line Platinum-Based Chemotherapy
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The purpose of this research study is to:
Test the effectiveness of the investigational study drug, afatinib, compared to erlotinib (a prescribed drug for treatment of lung cancer) as the second-line treatment (the initial treatment stopped working or the side effects were not well tolerated) for patients with advanced non-small cell squamous cell lung cancer – squamous cell type.
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Principal Investigator(s):
Paul J. Hesketh, MD
For more information about this Research Study call 781-744-8027.
Study Coordinator(s):
Julia C. Roache.
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N1048: A Phase II/III Trial of Neoadjuvant FOLFOX with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision
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This protocol compares the effects of standard treatment (chemotherapy and radiation) to chemotherapy and selective use of standard treatment before surgery for rectal cancer.
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Principal Investigator(s):
Keith E. Stuart, MD
For more information about this Research Study call 781-744-8027.
Study Coordinator(s):
Kathleen (Kai) Sherman.
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NSABP B-49: A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node Positive or High-Risk Node-Negative HER2-Negative Breast Cancer
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This study is being done to find out if a combination of just two chemotherapy drugs, docetaxel and cyclophosphamide, is as good as using different combinations of the chemotherapy drugs doxorubicin and cyclophosphamide, given with either docetaxel or paclitaxel, in treating your type of breast cancer. All of these drugs are used in standard combinations of chemotherapy for breast cancer.
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Principal Investigator(s):
Corrine Zarwan, MD
For more information about this Research Study call 781-744-8027.
Study Coordinator(s):
Kori D. Hesse.
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NSABP P-5: Statin Polyp Prevention Trial In Patients With Resected Colon Cancer
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This study will look at the effects, good and/or bad, of the drug rosuvastatin (also called Crestor®). Rosuvastatin is a type of drug called a statin. The main purpose of this study is to find out whether or not rosuvastatin is able to prevent colon polyps and CRC from occurring in patients who have already had a colon cancer removed by surgery.
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Principal Investigator(s):
Keith E. Stuart, MD
For more information about this Research Study call 781-744-8027.
Study Coordinator(s):
Kathleen (Kai) Sherman.
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PRESENT: Prevention of Recurrence in Early Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax™ Treatment
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The purpose of this study is to evaluate the safety and effectiveness of the investigational drug, NeuVax, in preventing the recurrence of node-positive (when cancer is found in the lymph nodes), early stage breast cancer, with low to intermediate HER2 expression (Her-2 negative). NeuVax is an investigational drug, which means it is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA). It is a protein vaccine being developed for use after completion of standard of care therapy for early stage breast cancer to potentially prevent recurrence of the cancer. The safety of NeuVax in humans has been tested in prior research studies. This study will continue to collect information on safety, and will test NeuVax’s effectiveness.
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Principal Investigator(s):
Corrine Zarwan, MD
For more information about this Research Study call 781-744-8027.
Study Coordinator(s):
Kori D. Hesse.
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Protocol For A Research Database For Hematopoietic Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries
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The goal of this research is to find ways to make bone marrow and PBSC transplants work better. Although the exact study for which Research Database data may be used is not known at this time, the following are types of studies in which these data may be included. These are studies to:
• Determine how well recipients recover from their transplant;
• Determine how recovery after a transplant can be improved;
• Determine how access to transplant for different groups of patients can be improved;
• Determine how well donors recover from the collection procedures.
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Principal Investigator(s):
Arthur P. Rabinowitz, MD
For more information about this Research Study call 781-744-8027.
Study Coordinator(s):
Donna R. Spencer,
Marlaine E. McLean, RN-BSN.
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RTOG 0920: A Phase III Study Of Postoperative Radiation Therapy (IMRT) +/- Cetuximab For Locally-Advanced Resected Head And Neck Cancer
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The purpose of this study is to compare the effects, good and/or bad, of radiation therapy alone with radiation therapy and cetuximab on you and your cancer to find out which is better. In this study, you will get either radiation therapy alone OR radiation therapy and cetuximab.
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Principal Investigator(s):
Francis W. Nugent, MD
For more information about this Research Study call 781-744-8027.
Study Coordinator(s):
Nevin Bhardwaj.
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RTOG 1016: Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer
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The purpose of this study is to compare the effects, good and/or bad, of two standard treatments for head and neck cancer: radiation therapy and cisplatin or radiation therapy and cetuximab. The two treatments may be comparable in treating your cancer, but radiation and cetuximab may result in less severe side effects.
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Principal Investigator(s):
Francis W. Nugent, MD
For more information about this Research Study call 781-744-8027.
Study Coordinator(s):
Nevin Bhardwaj.
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S0709, A Phase II Selection Design Of Pharmacodynamic Separation Of Carboplatin/Paclitaxel/OSI-774 (Erlotinib; NSC-718781) Or OSI-774 Alone In Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With Performance Status 2 (PS-2) Selected By Serum Proteomics
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The purpose of this study is to find out whether a pill, OSI-774 (erlotinib), with or without chemotherapy (carboplatin and paclitaxel) would be effective in controlling your lung cancer by either shrinking the tumor or preventing it from growing. This study will look into the effects of the planned therapy on your cancer if you have a certain level of a protein called epidermal growth factor receptor (EGFR).
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Principal Investigator(s):
Paul J. Hesketh, MD
For more information about this Research Study call 781-744-8027.
Study Coordinator(s):
Julia C. Roache.
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S0806, A Phase I/II Trial of Vorinostat (SAHA) (NSC-701852) in Combination with Rituximab-CHOP in Patients with Newly Diagnosed Advanced Stage Diffuse Large B-Cell Lymphoma (DLBCL)
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The standard treatment for DLBCL is a combination of the drugs rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (called "RCHOP"). In many patients with DLBCL the lymphoma can return (“relapse”) after treatment with RCHOP. Vorinostat is a drug that may be effective in treating DLBCL. This experimental study is being done to see how well the combination of vorinostat and RCHOP can work to reduce the chance of DLBCL returning.
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Principal Investigator(s):
Tarun Kewalramani, MD
For more information about this Research Study call 781-744-8027.
Study Coordinator(s):
Kathleen (Kai) Sherman.
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S0812, A Randomized, Double-Blind, Placebo-Controlled, Biomarker Modulation Study of High Dose Vitamin D in Premenopausal Women at High Risk for Breast Cancer, Phase IIB
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A biomarker is a biologic test (for example, a mammogram, tissue or blood test) which may predict who will develop breast cancer in the future. The purpose of this study is to see if vitamin D affects breast tissue by reducing breast tissue thickness (the amount of glandular breast tissue compared to fat) on a mammogram (a special imaging exam of the breast that uses x-rays) and if it reduces the growth of breast cells. Also, we want to find out what effects on the breast and also side effects vitamin D has.
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Principal Investigator(s):
Corrine Zarwan, MD
For more information about this Research Study call 781-744-8027.
Study Coordinator(s):
Julia C. Roache.
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S0819: A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel Or Carboplatin/Paclitaxel/Bevacizumab With Or Without Concurrent Cetuximab In Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
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The purpose of this study is compare the effects, good and/or bad, of the addition of cetuximab to the common treatment of carboplatin, paclitaxel and bevacizumab to the same drugs without cetuximab on you and your lung cancer to find out which is better.
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Principal Investigator(s):
Paul J. Hesketh, MD
For more information about this Research Study call 781-744-8027.
Study Coordinator(s):
Julia C. Roache.
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S1007: A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER-2 Negative Breast Cancer with Recurrence Score (RS) of 25 or Less
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The Oncotype DX® breast cancer test is a test that looks at multiple genes related to breast cancer. The combination of the test results produces a score that is useful in guiding treatment choices for patients with node-negative breast cancer. The higher the score, the more likely that the patient’s breast cancer will come back after surgery.
The Oncotype DX® test is a commercially available test that is already being used to assess the risk that breast cancer will come back after surgery. The performance of the test is not part of the research question in this study.
The purpose of this part of this experimental study is to send your breast cancer tissue for Oncotype DX® recurrence score testing to find out if you may be eligible to participate in the next part of the study.
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Principal Investigator(s):
Corrine Zarwan, MD
For more information about this Research Study call 781-744-8027.
Study Coordinator(s):
Deb Hanna, RN,
Jo A. Underhill,
Kori D. Hesse.
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