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Amyloidosis


A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis

The experimental drug used in this study is called daratumumab, or JNJ-54767414, a CD38 monoclonal antibody. The purpose of this study is to see if daratumumab when given with three other drugs [cyclophosphamide, bortezomib (VELCADE®) and dexamethasone] is useful for treating participants with Amyloid light chain Amyloidosis (also known as AL Amyloidosis). The study will look at what happens (both good and bad) when daratumumab is given with these three drugs compared to just giving those three drugs alone. The safety of daratumumab when given with cyclophosphamide, bortezomib and dexamethasone (CyBorD) will also be studied.

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Brain Cancer


METIS: Pivotal, open-label, randomized study of radiosurgery with or without Tumor Treating Fields (TTFields) for 1-10 brain metastases from non-small cell lung cancer (NSCLC).

The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1-10 brain metastases, treated with NovoTTF-100M compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

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Brain Tumors


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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METIS: Pivotal, open-label, randomized study of radiosurgery with or without Tumor Treating Fields (TTFields) for 1-10 brain metastases from non-small cell lung cancer (NSCLC).

The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1-10 brain metastases, treated with NovoTTF-100M compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

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Breast Cancer


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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Phase 1/2 Clinical Study of Niraparib in Combination with Pembrolizumab in Patients with Advanced or Metastatic Triple-Negative Breast Cancer and in Patients with Recurrent Ovarian Cancer

The purpose of this study is to test the effectiveness of the combination of niraparib and pembrolizumab in patients with triple negative breast cancer or ovarian cancer.

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Chronic Lymphocytic Leukemia


A Phase 2, Open-Label Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacodynamics of GS-9973 in Subjects with Relapsed or Refractory Hematologic Malignancies

The purpose of this study is to see if GS-9973 can benefit subjects with CLL, MCL, DLBCL, FL and other iNHLs.  This study will also investigate how safe GS-9973 is and how well the drug is tolerated.

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Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib (MK-7965) in Subjects with Hematologic Malignancies

This is a non-randomized, open-label study evaluating the safety and efficacy of pembrolizumab (MK-3475) used in combination with dinaciclib (MK-7965) in the treatment of relapsed or refractory chronic lymphocytic leukemia (rrCLL), multiple myeloma (rrMM), or diffuse large B-cell lymphoma (rrDLBCL) in up to 138 participants from multiple sites.

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Fallopian Tube Cancer


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

This randomized phase III trial studies whether changes in diet and physical activity can increase the length of survival without the return of cancer (progression-free survival) compared with usual care in patients with previously treated stage II, III, or IV ovarian, fallopian tube, or primary peritoneal cancer. A healthy diet and physical activity program and counseling may help patients make healthier lifestyle choices. It is not yet known whether changes in diet and exercise may help increase progression-free survival in patients with previously treated cancer.

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Gastrointestinal Tumors


A Phase 1b/2 Study of Ibrutinib Combination Therapy in Selected Advanced Gastrointestinal And Genitourinary Tumors

The purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination treatment of ibrutinib with everolimus, paclitaxel, docetaxel, or cetuximab in selected advanced gastrointestinal and genitourinary tumors.

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Genitourinary Tumors


A Phase 1b/2 Study of Ibrutinib Combination Therapy in Selected Advanced Gastrointestinal And Genitourinary Tumors

The purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination treatment of ibrutinib with everolimus, paclitaxel, docetaxel, or cetuximab in selected advanced gastrointestinal and genitourinary tumors.

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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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A Two-arm, Open-label, Randomized Phase II Study of Pembrolizumab (MK-3475) Monotherapy Versus Standard Chemotherapy in Platinum Pre-treated, Recurrent or Metastatic Nasopharyngeal Cancer (NPC) (Keynote-122)

This is a study of pembrolizumab versus standard of care (SOC) treatment (capecitabine, gemcitabine, or docetaxel) for the treatment of recurrent or metastatic nasopharyngeal cancer (NPC). Participants will be randomly assigned to receive either pembrolizumab or Investigator's choice of standard treatment.

The primary study hypothesis is that pembrolizumab treatment prolongs progression-free survival (PFS) and overall survival (OS) when compared to SOC treatment.

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Hematologic Disorders


Epideermal Growth Factor (EGF) Analysis in Patients with Plasma Cell Diseases

The purpose of this study is to perform interval urine analyses in patients with plasma cell diseases to determine if epidermal growth factor (EGF) can serve as a clinically useful indicator of kidney function over time in this patient population. This study will enroll 100 plasma cell disease patients over 2 years. No additional visits for this study are required. Patients will make interval donations of first morning urine samples that coordinate with standard follow-up clinic visits to Tufts Medical Center. The patient will bring their first morning urine to Tufts Medical Center in provided container, and the study team will bring the sample to the laboratory for EGF analysis.

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Hematologic Malignancies


A Phase 2, Open-Label Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacodynamics of GS-9973 in Subjects with Relapsed or Refractory Hematologic Malignancies

The purpose of this study is to see if GS-9973 can benefit subjects with CLL, MCL, DLBCL, FL and other iNHLs.  This study will also investigate how safe GS-9973 is and how well the drug is tolerated.

More

Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib (MK-7965) in Subjects with Hematologic Malignancies

This is a non-randomized, open-label study evaluating the safety and efficacy of pembrolizumab (MK-3475) used in combination with dinaciclib (MK-7965) in the treatment of relapsed or refractory chronic lymphocytic leukemia (rrCLL), multiple myeloma (rrMM), or diffuse large B-cell lymphoma (rrDLBCL) in up to 138 participants from multiple sites.

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Herpes Zoster


Supportive Care: Efficacy, Safety, And Immunogenicity of Herpes Zoster Vaccine after Autologous Transplantation

This study is to test whether or not an investigational vaccine works to protect against a condition called “shingles,” which is caused by the Herpes Zoster virus. The vaccine will be tested in people who have received a transplant with their own blood stem cells. Subjects are either planning to receive this type of transplant or just received the transplant. Shingles is caused by the same virus that causes chickenpox. After that, the virus stays in the body but is asleep. A person can get shingles when the virus wakes up. If a person's immune system (resistance to disease) is weakened, the risk of getting shingles increases. This can happen after an autologous transplant with blood stem cells, so the researchers for this study are trying to find new ways to protect against this condition.

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Hodgkin Lymphoma


A Phase I Study With an Expansion Cohort of the Combinations of Ipilimumab, Nivolumab and Brentuximab Vedotin in Patients With Relapsed/Refractory Hodgkin Lymphoma

This phase I trial studies the side effects and best dose of ipilimumab and nivolumab when given together with brentuximab vedotin in treating patients with Hodgkin lymphoma that has returned after a period of improvement or has not responded to previous treatment.

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Leptomeningeal Metastases


NeMeRe, a Multi-Institutional Retrospective and Prospective Registry of Neoplastic Meningitis in Adults

This research is being done to collect information about adults with neoplastic meningitis. Tufts Medical Center and several other selected national sites will gather information about adults with neoplastic meningitis so that we can better understand this condition, the treatments that people with neoplastic meningitis receive, and how these treatments help them.

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Lymphomas


A Phase 2, Open-Label Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacodynamics of GS-9973 in Subjects with Relapsed or Refractory Hematologic Malignancies

The purpose of this study is to see if GS-9973 can benefit subjects with CLL, MCL, DLBCL, FL and other iNHLs.  This study will also investigate how safe GS-9973 is and how well the drug is tolerated.

More

Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib (MK-7965) in Subjects with Hematologic Malignancies

This is a non-randomized, open-label study evaluating the safety and efficacy of pembrolizumab (MK-3475) used in combination with dinaciclib (MK-7965) in the treatment of relapsed or refractory chronic lymphocytic leukemia (rrCLL), multiple myeloma (rrMM), or diffuse large B-cell lymphoma (rrDLBCL) in up to 138 participants from multiple sites.

More

Mantle Cell Lymphoma


A Phase 2, Open-Label Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacodynamics of GS-9973 in Subjects with Relapsed or Refractory Hematologic Malignancies

The purpose of this study is to see if GS-9973 can benefit subjects with CLL, MCL, DLBCL, FL and other iNHLs.  This study will also investigate how safe GS-9973 is and how well the drug is tolerated.

More

Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib (MK-7965) in Subjects with Hematologic Malignancies

This is a non-randomized, open-label study evaluating the safety and efficacy of pembrolizumab (MK-3475) used in combination with dinaciclib (MK-7965) in the treatment of relapsed or refractory chronic lymphocytic leukemia (rrCLL), multiple myeloma (rrMM), or diffuse large B-cell lymphoma (rrDLBCL) in up to 138 participants from multiple sites.

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Multiple Myeloma


A Phase 2b, Open-Label, Single-Arm Study of Selinexor (KPT-330) Plus Low- Dose Dexamethasone (Sd) in Patients With Multiple Myeloma Previously Treated With Lenalidomide, Pomalidomide, Bortezomib, Carfilzomib, and an Anti-CD38 Monoclonal Antibody (mAb) and Refractory to Prior Treatment With Glucocorticoids, an Immunomodulatory Agent, a Proteasome Inhibitor and an Anti-CD38 mAb

This is a Phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus dexamethasone 20 mg (Sd) dosed twice weekly in four-week cycles, in patients with penta-refractory MM (Parts 1 and 2) or quad refractory MM (Part 1 only).

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A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation

This study will assess whether taking ixazomib as maintenance therapy after standard treatments extends the period of time that a patient’s cancer stays inactive.

Maintenance therapy means that a drug is taken for a relatively long period (in this study, up to 24 months) to prolong the time that the myeloma remains under control after a prior therapy; in this study the prior therapy must not include autologous stem cell transplant.  It is not yet proven whether maintenance therapy given to people with multiple meyloma is better than waiting until the myeloma comes back to receive additional treatment.  The study will assess whether taking ixazomib immediately after responding to a prior therapy allows people with multiple myeloma to live longer by preventing or delaying the return of their disease.

This study is also being performed for these additional research purposes:

  • To evaluate the safety of ixazomib and to learn about the side effects associated with the use of this drug when it is used as a maintenance therapy.
  • To find out whether the presence of certain genes and proteins in the cancer cells of patients with multiple myeloma can predict whether ixazomib will work on cancers similar to yours.
  • To evaluate the health and overall well-being of patients while they are taking ixazomib.

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    Myelodysplastic Syndromes


    A Phase III, International, Randomized, Controlled Study of Rigosertib versus Physician’s Choice of Treatment in Patients with Myelodysplastic Syndrome after Failure of a Hypomethylating Agent

    The primary objective of this study is to compare the overall survival (OS) of patients receiving intravenous (IV) rigosertib to the OS of patients receiving the physician’s choice of treatment (PC) in a population of patients with myelodysplastic syndrome (MDS) after failure of treatment with a hypomethylating agent (HMA), azacitidine (AZA) or decitabine (DEC).

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    A Randomized Phase 2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of Venetoclax in Combination with Azacitidine Compared with Azacitidine Alone in Subjects with Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)

    This is a Phase 2, open-label, 3-arm randomized, multicenter study designed to determine the safety, pharmacokinetics, and efficacy of venetoclax when administered with azacitidine, compared to azacitidine alone, in subjects with treatment-naïve higher-risk MDS.

    Approximately 90 subjects, from approximately 50 sites, will be enrolled with approximately 30 subjects to be randomized to each arm.

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    Neuroblastoma


    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


    METIS: Pivotal, open-label, randomized study of radiosurgery with or without Tumor Treating Fields (TTFields) for 1-10 brain metastases from non-small cell lung cancer (NSCLC).

    The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1-10 brain metastases, treated with NovoTTF-100M compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

    More

    Ovarian Cancer


    A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Assess the Efficacy and Safety of Farletuzumab (MORAb-003) in Combination with Carboplatin plus Paclitaxel or Carboplatin plus  Pegylated Liposomal Doxorubicin (PLD) in Subjects with Low CA125 Platinum-Sensitive Ovarian Cancer

    This research is being done to find out if carboplatin plus paclitaxel or carboplatin plus Pegylated Liposomal Doxorubicin (PLD), chemotherapies (anticancer drugs) that are used to treat ovarian cancer, work better alone or when given with an investigational drug called farletuzumab.

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

    This randomized phase III trial studies whether changes in diet and physical activity can increase the length of survival without the return of cancer (progression-free survival) compared with usual care in patients with previously treated stage II, III, or IV ovarian, fallopian tube, or primary peritoneal cancer. A healthy diet and physical activity program and counseling may help patients make healthier lifestyle choices. It is not yet known whether changes in diet and exercise may help increase progression-free survival in patients with previously treated cancer.

    More

    Phase 1/2 Clinical Study of Niraparib in Combination with Pembrolizumab in Patients with Advanced or Metastatic Triple-Negative Breast Cancer and in Patients with Recurrent Ovarian Cancer

    The purpose of this study is to test the effectiveness of the combination of niraparib and pembrolizumab in patients with triple negative breast cancer or ovarian cancer.

    More

    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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    Peritoneal Cancer


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

    This randomized phase III trial studies whether changes in diet and physical activity can increase the length of survival without the return of cancer (progression-free survival) compared with usual care in patients with previously treated stage II, III, or IV ovarian, fallopian tube, or primary peritoneal cancer. A healthy diet and physical activity program and counseling may help patients make healthier lifestyle choices. It is not yet known whether changes in diet and exercise may help increase progression-free survival in patients with previously treated cancer.

    More

    Renal Disease


    Epideermal Growth Factor (EGF) Analysis in Patients with Plasma Cell Diseases

    The purpose of this study is to perform interval urine analyses in patients with plasma cell diseases to determine if epidermal growth factor (EGF) can serve as a clinically useful indicator of kidney function over time in this patient population. This study will enroll 100 plasma cell disease patients over 2 years. No additional visits for this study are required. Patients will make interval donations of first morning urine samples that coordinate with standard follow-up clinic visits to Tufts Medical Center. The patient will bring their first morning urine to Tufts Medical Center in provided container, and the study team will bring the sample to the laboratory for EGF analysis.

    More

    Solid Tumors


    A Phase 1b/2 Study of Ibrutinib Combination Therapy in Selected Advanced Gastrointestinal And Genitourinary Tumors

    The purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination treatment of ibrutinib with everolimus, paclitaxel, docetaxel, or cetuximab in selected advanced gastrointestinal and genitourinary tumors.

    More

    Transplant


    Supportive Care: Efficacy, Safety, And Immunogenicity of Herpes Zoster Vaccine after Autologous Transplantation

    This study is to test whether or not an investigational vaccine works to protect against a condition called “shingles,” which is caused by the Herpes Zoster virus. The vaccine will be tested in people who have received a transplant with their own blood stem cells. Subjects are either planning to receive this type of transplant or just received the transplant. Shingles is caused by the same virus that causes chickenpox. After that, the virus stays in the body but is asleep. A person can get shingles when the virus wakes up. If a person's immune system (resistance to disease) is weakened, the risk of getting shingles increases. This can happen after an autologous transplant with blood stem cells, so the researchers for this study are trying to find new ways to protect against this condition.

    More