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Amyloidosis


A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction

This is a global, multicenter, Phase 2b, randomized, double-blind, placebo-controlled, two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered intravenously in adults with AL amyloidosis who had a hematologic response to previous treatment for their amyloidosis (e.g., chemotherapy, autologous stem cell transplant [ASCT]) and have persistent cardiac dysfunction.

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A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care vs. Placebo Plus Standard of Care in Subjects with Light Chain (AL) Amyloidosis

The purpose of this study is to evaluate whether NEOD001, the study drug, will improve survival in subjects with AL amyloidosis and/or increase the interval of time that they can go without requiring hospitalization for problems with their hearts.  This study will also evaluate whether NEOD001 improves the function of subjects’ organs that have been affected by amyloid deposits.

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Brain Tumors


A Phase II Trial of Nifurtimox for Refractory or Relapsed Neuroblastoma or Medulloblastoma

This study is being done to test the effect of a drug, nifurtimox, against neuroblastoma and medulloblastoma in children. Nifurtimox is a drug that has been used in South America for many years to treat a parasitic disease known as Chagas Disease. It is not approved by the Food and Drug Administration for routine use in neuroblastoma or medulloblastoma in the United States, but the FDA is allowing it to be used in research studies like this one. Limited early observations, suggest that nifurtimox may have anti-tumor activity for neuroblastoma and medulloblastoma. We do not know whether nifurtimox will shrink/kill tumor cells effectively in children. Therefore, the major goal of the study is to learn if nifurtimox in combination with other common chemotherapy drugs is effective in shrinking/killing neuroblastoma and medulloblastoma cells. We will also be collecting information about any side effects that the drug may have.

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A Randomized, Phase III Trial Of Memantine and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Patients With Brain Metastases

The purpose of this study is to compare any good and bad effects of avoiding the hippocampus during whole-brain radiation plus memantine to using the usual whole-brain radiation plus memantine. The hippocampus is a brain structure that is important for memory. The addition of the hippocampal avoidance technique to the usual whole-brain radiation plus memantine will decrease the dose of radiation to your hippocampus. It is hoped hippocampal avoidance technique will decrease the chance of cognitive side effects, however it is possible hippocampal avoidance could have no impact on cognitive side effects and could even cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. Memantine is already FDA-approved for use in patients with dementia and is commonly used off-label (that is, for a purpose for which it is not FDA approved) for patients receiving whole-brain radiation therapy for cancer that has spread to the brain.

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A Randomized, Placebo Controlled Phase 2b/3 Study of ABT-414 with Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects with Newly Diagnosed Glioblastoma (GBM) with Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance 1)

The main purposes of this study are to evaluate whether combining ABT-414 with usual RT and TMZ treatment controls GBM better than usual RT and TMZ without ABT-414, and whether ABT-414 makes patients live longer. This study will only include people whose tumors are tested and confirmed to have EGFR amplification.

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A071101: A Phase II Randomized Trial Comparing the Efficacy of Heat Shock Protein-Peptide Complex-96 (HSPPC-96) (NSC #725085, Alliance IND# 15380) Vaccine Given with Bevacizumab Versus Bevacizumab Alone in the Treatment of Surgically Resectable Recurrent Glioblastoma Multiforme (GBM)

The purpose of this study is to compare the effects of a vaccine called heat shock protein peptide complex 96 (HSPPC-96) given with a drug called bevacizumab to bevacizumab alone. HSPPC-96 is experimental and is made from tissue taken from the brain tumor. Specifically, HSPPC-96 is a protein (a naturally occurring substance) that is taken from a person's brain tumor tissue and given back to them in the form of a preparation called a vaccine that may work to help their body have a response against remaining brain tumor cells. Bevacizumab blocks a protein called VEGF (Vascular Endothelial Growth Factor), which is produced by normal cells but over produced by cancer cells. Bevacizumab has been approved by the Food and Drug administration for treating brain tumors that grow back. In this study, subjects will either get HSPPC-96 vaccine at the same time as bevacizumab, HSPPC vaccine first and then bevacizumab if their tumor comes back, or bevacizumab alone. The use of HSPPC-96 in combination with bevacizumab is also investigational

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A221101: A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients with High Grade Glioma

The purpose of this study is to:  1) see if taking the study agent, armodafinil, at a dose of 150mg or 250mg, will improve problems with fatigue in subjects who have been diagnosed with cancer and are experiencing fatigue; and 2) see the effects (good and bad) of taking Armodafinil compared to placebo (an inactive agent) on cancer related fatigue. In this study, subjects will take either the study agent, armodafinil, or the placebo (inactive agent).  Subjects will not take both. Armodafinil (Nuvigil®) is a medicine that is currently FDA approved to promote wakefulness in people who have sleep disorders.   However, it is not been studied in people with cancer related fatigue.

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Phase I/II Dose Escalation Trial to Assess Safety of Intrathecal Trastuzumab for the Treatment of Leptomeningeal Metastases in HER2 Positive Cancer

The purpose of this the study that you are now being asked to participate in is to determine how safe and effective the study drug, trastuzumab, is in patients with HER-2 positive cancer that has spread to the fluid around the brain and spinal cord.

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Phase II Trial Of SMO/AKT/NF2 Inhibitors In Progressive Meningiomas With SMO/AKT/ NF2 Mutations

The purpose of this study is to test good and bad effects of two different drugs against meningioma tumors with altered genes. Today, therapy for meningioma is the same for all patients, and is not based on tumor genetic testing. This trial is trying to see if tumor genetic testing would be helpful at guiding treatment in meningioma patients. Researchers have looked at the DNA material (genes) that can be affected in meningioma and have found several genes that are altered, or mutated. These include the genes called SMO and NF2. When the SMO or NF2 genes are altered, it can cause a tumor to grow. There are drugs that target these 2 genes.

The study drug, vismodegib, blocks the SMO receptor. Vismodegib has already been FDA-approved to treat basal cell cancer, which is a type of skin cancer. Vismodegib could shrink cancer, but it could also cause side effects. The study drug, GSK2256098, blocks FAK, and seems to work better in tumors that have NF2-mutations. GSK2256098 has been tested in other cancers. Researchers hope to learn if either of the study drugs will shrink cancer.

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Randomized Phase II Trial of Hypofractionated Dose-Escalated Photon IMRT or Proton Beam Therapy Versus Conventional Photon Irradiation With Concomitant and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma

The purpose of this study is to compare a different radiation schedule and higher radiation dose [higher dose group] to the standard dose of radiation [standard dose group]. Both groups will receive usual chemotherapy, temozolomide. The higher radiation dose could shrink brain cancer, but it could also cause side effects. This study will allow the researchers to know whether this higher dose is better, the same, or worse than the usual approach.

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Breast Cancer


A Cohort Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS)

This research is being done to find out what effects, good and/or bad, that anastrozole has on women and whether their genes can help explain how anastrozole affects them. Specifically, many women who take anastrozole, or one of the other aromatase inhibitors (letrozole or exemestane) during treatment for breast cancer report muscle and joint aches; however, the reasons that lead to these symptoms are not known. These symptoms have been called “aromatase inhibitor-associated musculoskeletal syndrome” (or AIMSS). Small studies have suggested that a person’s genetic information may help us to develop a way to predict who will develop side effects and how best to treat them, and we hope to collect information in this study to look at this more closely. In addition, we hope to look at how the side effects from hormone therapy influence quality of life and a patient’s willingness to continue hormonal treatment.

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A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients with HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and Require Systemic Treatment

The purpose of this study is to determine whether patients treated with margetuximab plus chemotherapy have longer progression free survival and overall survival than patients treated with trastuzumab plus chemotherapy.

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A Phase II Randomized Controlled Trial of Genomically Directed Therapy After Preoperative Chemotherapy in Patients with Triple Negative Breast Cancer

The purpose of this study is to test the theory that therapy designed for each individual’s tumor will improve outcomes over standard of care in a population that needs a better standard. Using tumor tissue samples from a prior surgery, treatment reccomendations will be made based on DNA sequencing of the tumor cells by a Cancer Genomics Tumor Board facilitated by the Hoosier Cancer Research Network. Subjects will be randomized to one of several treatment options based on their specific tumor genetic make-up, prior treatment history and tolerance, and medical history.

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A phase III, randomized, open label, multicenter, controlled trial of niraparib versus physician’s choice in previously-treated, HER2 negative, germline BRCA mutation-positive breast cancer patients.

The purpose of this study is to compare the effects, both good and/or bad, of giving participants either niraparib or the standard chemotherapy for HER2-negative , BRCA mutation positive breast cancer to find out which is better

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A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer

This study is looking to determine whether the addition of carboplatin to an adjuvant chemotherapy regimen of doxorubicin/cyclophosphamide followed by paclitaxel will improve invasive disease-free survival compared to treatment without carboplatin.

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Breast Cancer - Determining Effect of MGAH22 in Breast Cancer Patients

To determine if MGAH22 has sufficient activity in the population of breast cancer participants whose tumors exhibit 2+ HER2 oncoprotein expression and lacks HER2 gene amplification.

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Palbociclib Collaborative Adjuvant Study: A randomized phase III trial of Palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for hormone receptor positive (HR+) / human epidermal growth factor receptor 2 (HER2)-negative early breast cancer

The purpose of this study is to compare any good and bad effects of using 2 years of Palbociclib in combination with standard anti-hormone therapy to using standard anti-hormone therapy alone and to evaluate the likelihood that invasive breast cancer returns.

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Crohn's Disease


A Long-Term Non-Invasive Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Pediatric Patients with Moderately to Severly Active Crohn’s Disease

To find out more about children with Crohn’s Disease (CD) to help doctors improve the care of patients with this disease.

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A Multicenter, Prospective, Long-Term, Observational Registry of Pediatric Patients with Inflammatory Bowel Disease

A study designed to gain additional information on pediatric patients with Inflammatory Bowel Disease…Crohn’s Disease, Ulcerative Colitis, and Indeterminate Colitis

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Diabetes


Vitamin D and Type 2 Diabetes (D2d) Study

A clinical trial to test whether taking vitamin D daily lowers the risk of diabetes in people who are at high risk for diabetes (e.g. overweight, older than 40 years, family history of diabetes, or had diabetes during pregnancy). Participants will take 1 pill a day (vitamin D or placebo) for the duration of the 4 year study. Participants will visit the study site for up to 13 scheduled visits during their participation. All participants receive education on diabetes prevention and are monitored twice a year for diabetes.

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Diabetes Mellitus


Vitamin D and Type 2 Diabetes (D2d) Study

A clinical trial to test whether taking vitamin D daily lowers the risk of diabetes in people who are at high risk for diabetes (e.g. overweight, older than 40 years, family history of diabetes, or had diabetes during pregnancy). Participants will take 1 pill a day (vitamin D or placebo) for the duration of the 4 year study. Participants will visit the study site for up to 13 scheduled visits during their participation. All participants receive education on diabetes prevention and are monitored twice a year for diabetes.

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Diffuse Large B-Cell Lymphoma


Lenalidomide in Patients with Newly Diagnosed Diffuse Large B Cell Lymphoma

The purpose of this study is to find out what effects, good and/or bad, the addition of lenalidomide to standard chemotherapy (RCHOP) has on you and your cancer. Everybody in this study will receive standard chemotherapy. In addition to standard chemotherapy randomly chosen half of the subjects will receive a medication called lenalidomide. Adding lenalidomide to the standard chemotherapy RCHOP is considered experimental in diffuse large B cell lymphoma, and is not FDA approved. There is NO placebo (“sugar pill”) in this study, and everybody selected will receive an active medication.

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Eosinophilic Esophagitis


A Randomized, Double-Blind, Parallel, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Dupilumab in Adult Patients with Active Eosinophilic Esophagitis

The primary objective of the study is to assess the clinical efficacy of repeat subcutaneous (SC) doses of dupilumab, compared with placebo, to relieve symptoms in adult patients with active, moderate to severe eosinophilic esophagitis (EoE).

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Ependymoma


ACNS0831: Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 years

This study is being done to evaluate what effects, if any, chemotherapy can have when added to the standard of care for this type of cancer. The current standard of care for this type of cancer is a surgery, to remove as much of the tumor as possible, followed by radiation. It will look at if chemotherapy, when added to the standard of care, affects the cancer from coming back.

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Glioblastoma


Randomized Phase II Trial of Hypofractionated Dose-Escalated Photon IMRT or Proton Beam Therapy Versus Conventional Photon Irradiation With Concomitant and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma

The purpose of this study is to compare a different radiation schedule and higher radiation dose [higher dose group] to the standard dose of radiation [standard dose group]. Both groups will receive usual chemotherapy, temozolomide. The higher radiation dose could shrink brain cancer, but it could also cause side effects. This study will allow the researchers to know whether this higher dose is better, the same, or worse than the usual approach.

More

Glioma


A221101: A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients with High Grade Glioma

The purpose of this study is to:  1) see if taking the study agent, armodafinil, at a dose of 150mg or 250mg, will improve problems with fatigue in subjects who have been diagnosed with cancer and are experiencing fatigue; and 2) see the effects (good and bad) of taking Armodafinil compared to placebo (an inactive agent) on cancer related fatigue. In this study, subjects will take either the study agent, armodafinil, or the placebo (inactive agent).  Subjects will not take both. Armodafinil (Nuvigil®) is a medicine that is currently FDA approved to promote wakefulness in people who have sleep disorders.   However, it is not been studied in people with cancer related fatigue.

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Head and Neck Cancer


A Phase 1b/2, Open-Label, Multicentre Study Assessing the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of MEDI4736 in Combination With AZD9150 or AZD5069 in Patients With Advanced Solid Malignancies and Subsequently Comparing AZD9150 and AZD5069 Both as Monotherapy and in Combination With MEDI4736 as Second Line Treatment in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

This study is to evaluate the overall response rate of two experimental drugs, AZD9150 and AZD5069, both as single medicine treatments and in combination with another study drug,MEDI4736, in the second-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.

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Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)

There are two study questions we are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel 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 giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.

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Hepatitis B


A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi center Study to Evaluate the Safety and Efficacy of GS-9620 in combination with Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Subjects with Chronic Hepatitis B and who are currently not on Treatment

This is a randomized, double-blind, placebo-controlled, multicenter Phase 2 study to evaluate the safety and efficacy of administering either 1 mg, 2 mg or 4 mg of GS-9620 orally once a week (every 7 days) both in-clinic and at home for 12 doses (Weeks 0-11) in adult CHB subjects who are not currently on treatment for CHB.

Approximately 175 subjects will be randomized in a 1:2:2:2 ratio to one of the four treatment arms (A:B: C: D) for weekly dosing for a total of 12 doses. All subjects will also be treated with Tenofovir

Disoproxil Fumarate (TDF) 300 mg oral daily for 48 weeks. Randomization will be stratified by HBeAg status (positive vs. negative) and ALT (> vs. <19 IU/L for female; > vs. < 30 IU/L for male).

  • Treatment Arm A: 25 subjects administered TDF 300 mg oral daily + placebo orally once a week (every 7 days) for 12 doses
  • Treatment Arm B: 50 subjects administered TDF 300 mg oral daily + GS-9620 1 mg orally once a week every 7 days) for 12 doses
  • Treatment Arm C: 50 subjects administered TDF 300 mg oral daily +GS- 9620 2 mg orally once a week every 7 days) for 12 doses
  • Treatment Arm D: 50 subjects administered TDF 300 mg oral daily + GS-9620 4 mg orally once a week (every 7 days) for 12 doses

After Week 11, GS-9620/placebo will be discontinued. All subjects will continue receiving TDF and will be followed for 37 weeks (Week 48).

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High Blood Pressure


Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension

The REDUCE HTN: REINFORCE study is testing a new procedure that could treat high blood pressure.  This procedure is called renal (kidney) denervation.  The study will be evaluating patients that have high blood pressure when they do not take medications. The study will compare the blood pressure of people who undergo the study procedure (renal denervation) with the blood pressure of those who undergo a sham procedure (a renal angiogram that will not include the renal denervation). The study’s purpose is to collect data about the safety and effectiveness of this renal denervation (disabling of kidney nerves) treatment for patients with uncontrolled hypertension.

The Vessix™ Renal Denervation System consists of a catheter (a thin tube) and a radio frequency (RF) generator (power generator).  The procedure involves the nerves that surround the blood vessel (artery) that supplies blood to the kidney (kidney artery). The generator sends energy through the kidney artery to disable the surrounding nerves. These nerves have a role in causing the kidneys to keep sodium (salt) in the body and in causing the amount of blood flowing into the filters in the kidney to be lower. These two things, among others, can then cause high blood pressure.  By disabling these nerves, the Vessix system aims to reduce the amount of salt kept in the body and therefore reduce blood pressure in the body.

Renal denervation is not a treatment currently used for high blood pressure management in the U.S.  The device is investigational in the United States. It is not approved by the U.S. FDA. The sponsor of this study is Boston Scientific Corporation.  

The study will include 100 subjects at up to 20 hospitals in the US (about 20 of these subjects will be enrolled at Tufts Medical Center). About 67 people of the 100 total will get the renal denervation procedure (study group) and about 33 people will get a “sham” procedure (control group). People will be randomly selected to one or the other group.  The doctor doing the procedure will know which group you are in when he is doing the procedure. Your Study Doctor will tell you whether you received the renal denervation procedure or the sham procedure at your 6 month follow-up visit. Until then, neither you nor your Study Doctor will know which procedure you received. The sham procedure is done to get data that is not influenced by knowing what procedure you received.

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Hodgkin Lymphoma


A Phase I-II Trial of Brentuximab Vedotin Plus Rituximab as Frontline Therapy for Patients with CD30+ and/or EBV+ Lymphomas

The primary purpose of this study is to evaluate the safety of the combination of two different drugs (brentuximab vedotin and rituximab) in patients with certain types of lymphoma. This study is for patients who have a type of lymphoma that expresses a tumor marker called CD30 and/or a type that is associated with the Epstein-Barr virus (EBV-related lymphoma) and who have not yet received any treatment for their cancer, except for dose-reduction or discontinuation (stoppage) of medications used to prevent rejection of transplanted organs (for those patients who have undergone transplantation). These include, but are not limited to, diffuse large B-cell lymphoma (DLBCL), post-transplant lymphoproliferative disorder (PTLD), non-Hodgkin’s lymphoma (NHL), Hodgkin’s lymphoma (HL), and peripheral T-cell lymphoma (PTCL).  In addition, this study will attempt to evaluate how effective this combination of study drugs may be in addressing these types of lymphoma.

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Hypertension


Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension

The REDUCE HTN: REINFORCE study is testing a new procedure that could treat high blood pressure.  This procedure is called renal (kidney) denervation.  The study will be evaluating patients that have high blood pressure when they do not take medications. The study will compare the blood pressure of people who undergo the study procedure (renal denervation) with the blood pressure of those who undergo a sham procedure (a renal angiogram that will not include the renal denervation). The study’s purpose is to collect data about the safety and effectiveness of this renal denervation (disabling of kidney nerves) treatment for patients with uncontrolled hypertension.

The Vessix™ Renal Denervation System consists of a catheter (a thin tube) and a radio frequency (RF) generator (power generator).  The procedure involves the nerves that surround the blood vessel (artery) that supplies blood to the kidney (kidney artery). The generator sends energy through the kidney artery to disable the surrounding nerves. These nerves have a role in causing the kidneys to keep sodium (salt) in the body and in causing the amount of blood flowing into the filters in the kidney to be lower. These two things, among others, can then cause high blood pressure.  By disabling these nerves, the Vessix system aims to reduce the amount of salt kept in the body and therefore reduce blood pressure in the body.

Renal denervation is not a treatment currently used for high blood pressure management in the U.S.  The device is investigational in the United States. It is not approved by the U.S. FDA. The sponsor of this study is Boston Scientific Corporation.  

The study will include 100 subjects at up to 20 hospitals in the US (about 20 of these subjects will be enrolled at Tufts Medical Center). About 67 people of the 100 total will get the renal denervation procedure (study group) and about 33 people will get a “sham” procedure (control group). People will be randomly selected to one or the other group.  The doctor doing the procedure will know which group you are in when he is doing the procedure. Your Study Doctor will tell you whether you received the renal denervation procedure or the sham procedure at your 6 month follow-up visit. Until then, neither you nor your Study Doctor will know which procedure you received. The sham procedure is done to get data that is not influenced by knowing what procedure you received.

More

Inflammatory Bowel Disease


A Multicenter, Prospective, Long-Term, Observational Registry of Pediatric Patients with Inflammatory Bowel Disease

A study designed to gain additional information on pediatric patients with Inflammatory Bowel Disease…Crohn’s Disease, Ulcerative Colitis, and Indeterminate Colitis

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Joint Disorders


A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-02 (Disodium Zoledronate Tetrahydrate) Administered Orally to Subjects with Knee Osteoarthritis Associated with Bone Marrow Lesions.

This is a phase 3 trial for the treatment of knee osteoarthritis associated with bone marrow lesions. The purpose of the study is to determine whether a study medication, AXS02 (disodium zoledronate tetrahydrate) can reduce bone marrow lesions, and therefore alleviate pain associated with osteoarthritis of the knee. AXS02 is an investigational drug and subjects are monitored to see if it causes any adverse event. Maximum participation is 21 weeks and may include up to 14 visits to Tufts Medical Center. A total of approximately 346 subjects are planned for enrollment. Subjects who are eligible for the study will receive AXS02 or placebo during visits 4-8 (1 tablet per week for 6 weeks). The following 6 visits consist of a number of tests and procedures to gather data.

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Leukemia


AALL0932:  Treatment of Patients with Newly Diagnosed Standard Risk B-Precursor Acute Lymphoblastic Leukemia (ALL)

This is a protocol for people with newly diagnosed Standard Risk Acute Lymphoblastic Leukemia. The study is broken up into parts. Each part of the study will be exploring different phases of chemotherapy such as Induction, Post-Induction, and Maintenance. In each phase of the study, researchers will be testing different experimental drug regimens versus standard treatments to see which one works better. Additionally, participants will be grouped based on their risk level and may receive different  chemotherapy regimens based on their risk.

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AALL1131: A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (ALL) Testing Clofarabine (IND# 73789, NSC# 606869) in the Very High Risk Stratum

This study will look at how effective different combinations of chemotherapy are a preventing acute lymphoblastic leukemia from coming back.

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AALL1231: A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239; IND# 58443) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T- Lymphoblastic Leukemia (T-ALL) and T- Lymphoblastic Lymphoma (T-LLy)

The aims of this study are to improve treatment for T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLy). We want to see if adding bortezomib to the standard treatment reduces the chance that the cancer will come back.

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Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome

  1. To find out if subjects with down syndrome and standard risk acute myeloid leukemia can be treated with less treatment and still have successful outcomes.
  2. To find out if subjects with down syndrome and high risk acute myeloid leukemia can be successfully treated with stronger chemotherapy.

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Risk-Stratified Randomized Phase III Testing of Blinatumomab (IND#117467, NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)

This randomized phase III trial compares how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Monoclonal antibodies, such as blinatumomab, can block cancer growth by finding cancer cells and helping to kill them or carrying cancer-killing substances to them. It is not yet known whether standard combination chemotherapy is more effective than blinatumomab in treating relapsed B-cell acute lymphoblastic leukemia.

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Lung Cancer


An Open-label, Randomized Phase 3 Efficacy Study of ASP8273 vs Erlotinib or Gefitinib in First-line Treatment of Patients with Stage IIIB/IV Non-small Cell Lung Cancer Tumors with EGFR Activating Mutations SOLAR Study

The purpose of the study is to collect information to determine if an investigational drug called ASP8273 is effective, safe and comparable to the treatments erlotinib or gefitinib that are already approved in the US, Europe and Asia, respectively, for patients with your type of NSCLC.

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Phase 2, Parallel-Arm Study of MGCD265 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Activating Genetic Alterations in Mesenchymal- Epithelial Transition Factor

The main purpose of this study is to test whether subjects with lung cancer, with specific changes in the tumor genes, benefit from getting study drug, MGCD265.  Other objectives of the study include assessing the side effects of MGCD265 in subjects, and how much and how quickly drug is absorbed and cleared from the blood stream.

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RTOG 1306: A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non-small Cell Lung Cancer (NSCLC)

Cancer is a disease caused by alterations in the functions of genes within the cells. In approximately 15% of patients with non-small cell lung cancer, one of two genes is altered significantly (known as EGFR mutation or ALK rearrangement). Erlotinib, a pill, taken on a daily basis produces significant decrease in the size of tumors in patients with advanced stage lung cancer with EGFR mutation. Similarly, another pill, crizotinib, produces significant decrease in the size of tumors in patients with advanced stage lung cancer with ALK rearrangement. However it is not clear how useful these two drugs will be in patients with a less advanced form of lung cancer in the presence of these gene alterations.  The purpose of this study is to find out what effects, good and/or bad, one of the following treatments has on locally advanced, non-operable lung cancer with specific gene alterations (EGFR mutation or ALK rearrangement).

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Lymphomas


A Phase I-II Trial of Brentuximab Vedotin Plus Rituximab as Frontline Therapy for Patients with CD30+ and/or EBV+ Lymphomas

The primary purpose of this study is to evaluate the safety of the combination of two different drugs (brentuximab vedotin and rituximab) in patients with certain types of lymphoma. This study is for patients who have a type of lymphoma that expresses a tumor marker called CD30 and/or a type that is associated with the Epstein-Barr virus (EBV-related lymphoma) and who have not yet received any treatment for their cancer, except for dose-reduction or discontinuation (stoppage) of medications used to prevent rejection of transplanted organs (for those patients who have undergone transplantation). These include, but are not limited to, diffuse large B-cell lymphoma (DLBCL), post-transplant lymphoproliferative disorder (PTLD), non-Hodgkin’s lymphoma (NHL), Hodgkin’s lymphoma (HL), and peripheral T-cell lymphoma (PTCL).  In addition, this study will attempt to evaluate how effective this combination of study drugs may be in addressing these types of lymphoma.

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AALL1231: A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239; IND# 58443) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T- Lymphoblastic Leukemia (T-ALL) and T- Lymphoblastic Lymphoma (T-LLy)

The aims of this study are to improve treatment for T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLy). We want to see if adding bortezomib to the standard treatment reduces the chance that the cancer will come back.

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Lenalidomide in Patients with Newly Diagnosed Diffuse Large B Cell Lymphoma

The purpose of this study is to find out what effects, good and/or bad, the addition of lenalidomide to standard chemotherapy (RCHOP) has on you and your cancer. Everybody in this study will receive standard chemotherapy. In addition to standard chemotherapy randomly chosen half of the subjects will receive a medication called lenalidomide. Adding lenalidomide to the standard chemotherapy RCHOP is considered experimental in diffuse large B cell lymphoma, and is not FDA approved. There is NO placebo (“sugar pill”) in this study, and everybody selected will receive an active medication.

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Medulloblastoma


A Phase II Trial of Nifurtimox for Refractory or Relapsed Neuroblastoma or Medulloblastoma

This study is being done to test the effect of a drug, nifurtimox, against neuroblastoma and medulloblastoma in children. Nifurtimox is a drug that has been used in South America for many years to treat a parasitic disease known as Chagas Disease. It is not approved by the Food and Drug Administration for routine use in neuroblastoma or medulloblastoma in the United States, but the FDA is allowing it to be used in research studies like this one. Limited early observations, suggest that nifurtimox may have anti-tumor activity for neuroblastoma and medulloblastoma. We do not know whether nifurtimox will shrink/kill tumor cells effectively in children. Therefore, the major goal of the study is to learn if nifurtimox in combination with other common chemotherapy drugs is effective in shrinking/killing neuroblastoma and medulloblastoma cells. We will also be collecting information about any side effects that the drug may have.

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Neuroblastoma


A Phase II Trial of Nifurtimox for Refractory or Relapsed Neuroblastoma or Medulloblastoma

This study is being done to test the effect of a drug, nifurtimox, against neuroblastoma and medulloblastoma in children. Nifurtimox is a drug that has been used in South America for many years to treat a parasitic disease known as Chagas Disease. It is not approved by the Food and Drug Administration for routine use in neuroblastoma or medulloblastoma in the United States, but the FDA is allowing it to be used in research studies like this one. Limited early observations, suggest that nifurtimox may have anti-tumor activity for neuroblastoma and medulloblastoma. We do not know whether nifurtimox will shrink/kill tumor cells effectively in children. Therefore, the major goal of the study is to learn if nifurtimox in combination with other common chemotherapy drugs is effective in shrinking/killing neuroblastoma and medulloblastoma cells. We will also be collecting information about any side effects that the drug may have.

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ANBL1232: Utilizing Response and Biology-Based Risk Factors to Guide Therapy in Patients with Non-High-Risk Neuroblastoma: A Groupwide Historically Controlled Phase III Study

In this study we are using new biologic features, in addition to the standard risk factors, to help decide which subjects need treatment and what the best treatment is. People with non-high-risk NBL generally respond well to treatment and the majority of patients can be treated successfully with standard therapy. But standard therapy can include risks from surgery and/or side effects from chemotherapy.Based on the evaluation of non-high-risk NBL patients treated in the past, we think that we can change the amount of therapy for subjects and still treat the cancer successfully. Small studies have shown that some subjects can be watched without having surgery or getting chemotherapy and still have an excellent outcome. By not having surgery or lowering the amount of chemotherapy we hope to prevent complications and harmful side effects. For other subjects we think a change in therapy will treat the cancer more successfully.

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NMTT: Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO)

The purpose of this research study is to evaluate an investigational drug (DFMO) for Neuroblastoma that is in remission. Remission means that there are no current signs of active cancer. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). This study will look at the ability of this study drug to keep neuroblastoma in remission and will also look at the safety and tolerability of DFMO.

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Non Small Cell Lung Cancer


An Open-label, Randomized Phase 3 Efficacy Study of ASP8273 vs Erlotinib or Gefitinib in First-line Treatment of Patients with Stage IIIB/IV Non-small Cell Lung Cancer Tumors with EGFR Activating Mutations SOLAR Study

The purpose of the study is to collect information to determine if an investigational drug called ASP8273 is effective, safe and comparable to the treatments erlotinib or gefitinib that are already approved in the US, Europe and Asia, respectively, for patients with your type of NSCLC.

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Phase 2, Parallel-Arm Study of MGCD265 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Activating Genetic Alterations in Mesenchymal- Epithelial Transition Factor

The main purpose of this study is to test whether subjects with lung cancer, with specific changes in the tumor genes, benefit from getting study drug, MGCD265.  Other objectives of the study include assessing the side effects of MGCD265 in subjects, and how much and how quickly drug is absorbed and cleared from the blood stream.

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Non-Hodgkin Lymphoma


A Phase I-II Trial of Brentuximab Vedotin Plus Rituximab as Frontline Therapy for Patients with CD30+ and/or EBV+ Lymphomas

The primary purpose of this study is to evaluate the safety of the combination of two different drugs (brentuximab vedotin and rituximab) in patients with certain types of lymphoma. This study is for patients who have a type of lymphoma that expresses a tumor marker called CD30 and/or a type that is associated with the Epstein-Barr virus (EBV-related lymphoma) and who have not yet received any treatment for their cancer, except for dose-reduction or discontinuation (stoppage) of medications used to prevent rejection of transplanted organs (for those patients who have undergone transplantation). These include, but are not limited to, diffuse large B-cell lymphoma (DLBCL), post-transplant lymphoproliferative disorder (PTLD), non-Hodgkin’s lymphoma (NHL), Hodgkin’s lymphoma (HL), and peripheral T-cell lymphoma (PTCL).  In addition, this study will attempt to evaluate how effective this combination of study drugs may be in addressing these types of lymphoma.

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Osteoarthritis


A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-02 (Disodium Zoledronate Tetrahydrate) Administered Orally to Subjects with Knee Osteoarthritis Associated with Bone Marrow Lesions.

This is a phase 3 trial for the treatment of knee osteoarthritis associated with bone marrow lesions. The purpose of the study is to determine whether a study medication, AXS02 (disodium zoledronate tetrahydrate) can reduce bone marrow lesions, and therefore alleviate pain associated with osteoarthritis of the knee. AXS02 is an investigational drug and subjects are monitored to see if it causes any adverse event. Maximum participation is 21 weeks and may include up to 14 visits to Tufts Medical Center. A total of approximately 346 subjects are planned for enrollment. Subjects who are eligible for the study will receive AXS02 or placebo during visits 4-8 (1 tablet per week for 6 weeks). The following 6 visits consist of a number of tests and procedures to gather data.

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Ovarian Cancer


A Phase III study comparing single-agent olaparib or the combination of cediranib and olaparib to standard platinum-based chemotherapy in women with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer

The purpose of this study is to compare the effect on ovarian cancer of using either olaparib by itself or the combination of cediranib and olaparib to the usual chemotherapy given for ovarian cancer.

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Can diet and physical activity modulate ovarian, fallopian tube and primary peritoneal cancer progression-free survival?

The purpose of this study is to find out if a change in diet and exercise in women with ovarian, fallopian tube, or primary peritoneal cancer has an effect on the length of time someone is cancer free following initial treatment. Some studies suggest diet and exercise may improve survival for cancer patients, but no studies have been done to show if changes in diet and exercise can have an effect on cancer returning in women treated for ovarian, fallopian tube, or primary peritoneal cancer. Other goals include finding out if the changes in diet and exercise will improve your overall quality of life and your ability to be physically active. In addition, you may be asked if researchers can test some of your blood to measure carotenoid levels, which will tell them about the kind of foods you are eating, and examine your genes (DNA).

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Pancreatic Cancer


Nab-Paclitaxel (Abraxane®) Plus Gemcitabine In Subjects With Locally Advanced Pancreatic Cancer (LAPC): An International, Open-Label, Multi-Center, Phase 2 Study (LAPACT)

This clinical study is in subjects with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. The study treats all subjects with nab-Paclitaxel plus gemcitabine for approximately 6 months of treatment.

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Polycystic Kidney Disease


A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC 41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease

Living with the pain, high blood pressure, and other symptoms of autosomal dominant polycystic kidney disease (ADPKD) can be overwhelming. And because ADPKD may be passed from one generation to the next, you may have seen how it has affected your family and wonder how the disease will affect you.

If you have ADPKD, and have participated in a previous Tolvaptan research study, you may want to learn more about the Open Label clinical research study.

What is the Open Label study?

The purpose of the Open Label study is to evaluate the long-term safety and effectiveness of an investigational medication called tolvaptan in patients with ADPKD.

Who can participate?

You may be able to join the study if you:

  • Have participated in a previous Tolvaptan research study
  • Are diagnosed with ADPKD

What is the investigational medication?

Tolvaptan is being investigated in this study as a potential treatment to slow the progression of cyst growth in the kidneys of adults with ADPKD.

What are the potential risks and benefits?

Everyone who participates in a research study must first complete a screening visit. During the screening visit, the study doctor will explain to you the study details and the potential risks and benefits of participation in the study.

The information learned from the study and your participation may help us learn about how to develop future treatment options for people with ADPKD.

Study participation is voluntary. If you choose to participate, you may leave the study at any time for any reason. The study doctor and staff will be available to help you throughout the study and to address any questions you may have. Your health is very important to them.

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Preventive Medicine


CS SCARLETT: Covert Strokes – Semi-structured interviews of Clinicians Assessing Risk, Logical inference, and Equipoise of Treatments and Testing decisions

This study is a qualitative exploration of the beliefs, attitudes, and behaviors of clinicians who provide care for patients with covert brain infarcts (silent strokes). We hope to better understand how clinicians are currently approaching incidentally discovered strokes without apparent symptoms.

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CS SPECTRE: Covert Strokes – Semi-structured interviews of Patient Experiences, Concerns, information Transfer, and Risk Estimation

This study is a qualitative exploration of the experiences and concerns of patients following the detection of incidentally discovered strokes without apparent symptoms (covert strokes, or silent strokes). We hope to better understand the needs of patients in order to orient future studies in screening, treatment, and prevention to meet those needs.

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Seizures


A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SAGE-547 Injection in the Treatment of Subjects with Super-Refractory Status Epilepticus

The purpose of the study is to find out if SAGE-547 has any effect on continuous seizures and if it is safe to use in patients in super-refractory status epilepticus (SRSE). SAGE-547 Injection (SAGE-547) is an investigational drug being studied in patients with continuous seizures (seizures that have little or no break between them) that do not respond to seizure medications.

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Stroke


CS SCARLETT: Covert Strokes – Semi-structured interviews of Clinicians Assessing Risk, Logical inference, and Equipoise of Treatments and Testing decisions

This study is a qualitative exploration of the beliefs, attitudes, and behaviors of clinicians who provide care for patients with covert brain infarcts (silent strokes). We hope to better understand how clinicians are currently approaching incidentally discovered strokes without apparent symptoms.

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CS SPECTRE: Covert Strokes – Semi-structured interviews of Patient Experiences, Concerns, information Transfer, and Risk Estimation

This study is a qualitative exploration of the experiences and concerns of patients following the detection of incidentally discovered strokes without apparent symptoms (covert strokes, or silent strokes). We hope to better understand the needs of patients in order to orient future studies in screening, treatment, and prevention to meet those needs.

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Multicenter, randomized, double-blind, double-dummy, active-comparator, event-driven, superiority phase III study of secondary prevention of stroke and prevention of systemic embolism in patients with a recent Embolic Stroke of Undetermined Source (ESUS) comparing rivaroxaban 15 mg once daily with aspirin 100 mg

The purpose of this study is to find out whether a new anti-clotting medication called rivaroxaban leads to fewer blood clots in your brain (stroke) or in other blood vessels in your body when compared with aspirin.

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Secondary Stroke Prevention in Patients with Patent Foramen Ovale: The International PFO-Consortium

The purpose of this study is to learn more about how often people with PFOs have a second stroke after having the first one. This registry will investigate the impact of age, blood thinning drugs (such as aspirin and Coumadin), and closure of the PFO on the risk of stroke.

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Stroke Hyperglycemia Insulin Network Effort Trial

The purpose of this study is to find out the effects of controlling blood sugar within a narrow range by giving IV insulin in patients with high blood sugar within 12 hours of developing symptoms of a stroke. The study is to determine if giving IV insulin to people with high blood sugar and who have had a stroke can improve recovery as compared to those who receive insulin by an injection under the skin. Studies have shown that high blood sugar levels during a stroke could be associated with more damage to the brain than normal blood sugar levels. Blood sugar levels can be lowered with insulin. The five different insulins that will be used in this study are approved by the FDA and are approved for this use as well. A subject will be assigned to one of 2 study groups: IV insulin and subcutaneous insulin. The subject will have a 50% chance to be assigned in one of the two groups by an internet-based randomization system.

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