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Lymphoma, B-cell clinical trials

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NCT ID: NCT00054665 Completed - B-Cell Lymphoma Clinical Trials

PS-341 Alone and PS-341 Plus EPOCH Chemotherapy to Treat Non-Hodgkin's Lymphoma

Start date: February 2003
Phase: Phase 2
Study type: Interventional

This study will examine the safety and effectiveness of an experimental drug called Bortezomib (PS-341), given alone and in combination with a chemotherapy regimen called Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin and Filgrastim (EPOCH), in treating non-Hodgkin's B-cell lymphoma. In the laboratory, PS-341 kills lymphoma cells and makes them more sensitive to chemotherapy. The EPOCH treatment regimen includes the drugs doxorubicin, etoposide, vincristine, cyclophosphamide, prednisone, and filgrastim. Patients 18 years of age and older with an aggressive non-Hodgkin's lymphoma that has relapsed after treatment or is not responding to chemotherapy may be eligible for this study. Candidates will be screened with a medical history and physical examination. Other tests that may be required include blood and urine tests; lung function studies; imaging tests such as magnetic resonance imaging, computed tomography and x-rays; and biopsy (surgical removal of a small tissue sample) of tumor, bone marrow, or other tissue. Upon entering the study, all participants will receive PS-341. The drug is given as a 3- to 5-second intravenous (through a vein) injection twice a week for 2 weeks. This is followed by a 1-week rest. Each 3-week period comprises one treatment cycle. The number of cycles a patient receives depends on how well he or she responds to the drug. Patients who do not have a complete remission or whose tumor grows on this therapy will be offered PS-341 in combination with up to six cycles of EPOCH chemotherapy. The treatment for patients taking PS-341 plus EPOCH is as follows: - PS-341, given by 3- to 5-second intravenous (IV) injection on days 1 and 4 of each cycle. - Doxorubicin, etoposide, and vincristine, given by continuous IV infusion over 4 days, beginning on day 1 and ending on day 5 of each cycle. The drugs are delivered through a lightweight portable infusion pump to an indwelling IV catheter (plastic tube) in a vein. - Cyclophosphamide, given by IV infusion over 15 minutes on day 5 of each cycle. - Prednisone, given by mouth (pills) twice a day on days 1 through 5 of each cycle. - Filgrastim, given by injection under the skin starting on day 6 of each cycle and continuing until the white blood cell count increases or until day 19 of the cycle. Patients also take a combination of antibiotics 3 days a week during EPOCH to prevent infection while resistance is lowered because of the chemotherapy. Etoposide, doxorubicin, and cyclophosphamide doses are adjusted as needed, based on white blood cell counts of the previous cycle. The first patients in the study will receive a low dose of PS-341. The dose will be increased in subsequent small groups of patients as long as the preceding dose is well tolerated. Drug therapy for patients who are candidates for bone marrow transplant will be tailored to permit transplantation. Patients who are not eligible for or who choose not to have a bone marrow transplant will be followed at the National Institutes of Health (NIH) every 3 months the first year, every 4 months the second year, every 6 months the third year, and then once a year until their disease progresses or the study ends. Patients may have tumor and bone marrow biopsies, blood draws, and computed tomography (CT) scans periodically to evaluate disease status and drug side effects.

NCT ID: NCT00054639 Completed - Clinical trials for Recurrent Mantle Cell Lymphoma

Oblimersen Sodium and Rituximab in Treating Patients With Recurrent B-cell Non-Hodgkin Lymphoma

Start date: January 2003
Phase: Phase 2
Study type: Interventional

The goal of this clinical research study is to learn if the combination of oblimersen sodium and rituximab can help to shrink or slow the growth of the tumor in patients with B-cell non-Hodgkin's lymphoma who have not responded to earlier treatment. Oblimersen Sodium is an investigational drug. The safety of this combination treatment will also be studied

NCT ID: NCT00054483 Completed - Clinical trials for Unspecified Adult Solid Tumor, Protocol Specific

Bortezomib in Treating Patients With Advanced Cancer and Kidney Dysfunction

Start date: January 2003
Phase: Phase 1
Study type: Interventional

Phase I trial to study the effectiveness of bortezomib in treating patients who have advanced cancer and kidney dysfunction. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

NCT ID: NCT00051597 Completed - Lymphoma, B-Cell Clinical Trials

A Safety/Efficacy Study of SGN-30 (Antibody) in Patients With Refractory or Recurrent CD30+ Hematologic Malignancies

Start date: n/a
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate a multi-dose regimen of SGN-30, a novel chimeric monoclonal antibody (mAb), in patients with refractory or recurrent CD30+ hematologic malignancies. This is a single-arm, open-label phase I/II study designed to define the toxicity profile, pharmacokinetic (PK) profile, and anti-tumor activity of a multi-dose regimen of SGN-30 in patients with refractory or recurrent CD30+ hematologic malignancies. The phase I study will be a modified dose escalation of SGN-30. Based on preclinical pharmacology and toxicokinetics (TK) and the first use in human single-dose phase I study, SGN-30 will be administered on a weekly schedule. An initial dose of 2 mg/kg will escalate until the maximum tolerated dose (MTD) has been reached or until a weekly dose of 12 mg/kg is achieved.

NCT ID: NCT00051025 Completed - Clinical trials for Non-Hodgkin's Lymphoma

Phase II Study of ONTAK in Previously Treated Patients With Low-grade Non-Hodgkin's Lymphoma (NHL)

Start date: May 2000
Phase: Phase 2
Study type: Interventional

The purpose of this study is to look at the safety and effectiveness of ONTAK in previously treated patients with NHL.

NCT ID: NCT00049504 Completed - Clinical trials for Recurrent Mantle Cell Lymphoma

Fludarabine Phosphate, Cyclophosphamide, Tacrolimus, Mycophenolate Mofetil, Total-Body Irradiation, and Donor Bone Marrow Transplant in Treating Patients With High-Risk Hematologic Cancer

Start date: January 2002
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well giving fludarabine phosphate, cyclophosphamide, tacrolimus, mycophenolate mofetil and total-body irradiation together with a donor bone marrow transplant works in treating patients with high-risk hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate and cyclophosphamide, and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells by stopping them from dividing or killing them. Giving cyclophosphamide after transplant may also stop the patient's immune system from rejecting the donor's bone marrow stem cells. The donated stem cells may replace the patient's immune system cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil after the transplant may stop this from happening

NCT ID: NCT00042666 Completed - Clinical trials for Non-Hodgkin's Lymphoma

A Study of Oral LY317615 in Relapsed or Refractory Diffuse Large B-Cell Lymphomas.

Start date: June 2002
Phase: Phase 2
Study type: Interventional

This study will measure the effectiveness and any side effects of LY317615 in participants with diffuse large B-cell lymphoma (DLBCL: a sub-type of Non-Hodgkins Lymphoma).

NCT ID: NCT00040846 Completed - Clinical trials for Recurrent Mantle Cell Lymphoma

Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies

Start date: November 2001
Phase: Phase 2
Study type: Interventional

This phase II trial studies the side effects and the best dose of alemtuzumab when given together with fludarabine phosphate and low-dose total body irradiation (TBI) and how well it works before donor stem cell transplant in treating patients with hematological malignancies. Giving chemotherapy and low-dose TBI before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine (CSP) and mycophenolate mofetil (MMF) after transplant may stop this from happening.

NCT ID: NCT00038571 Completed - Lymphoma, B-Cell Clinical Trials

Proteasome Inhibitor PS-341 Relapsed or Refractory B Cell Lymphomas Previously Treated With Chemotherapy

Start date: May 2002
Phase: Phase 2
Study type: Interventional

Purpose of Phase II study for B-cell lymphoma using PS341: Evaluate efficacy and toxicity of bortezomib in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.

NCT ID: NCT00026182 Completed - Clinical trials for Recurrent Mantle Cell Lymphoma

Rituximab and Interleukin-12 in Treating Patients With B-Cell Non-Hodgkin's Lymphoma

Start date: October 2001
Phase: Phase 2
Study type: Interventional

Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Interleukin-12 may kill cancer cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Combining rituximab with interleukin-12 may kill more cancer cells. This randomized phase II trial is comparing how well giving rituximab together with two different schedules of interleukin-12 works in treating patients with B-cell non-Hodgkin lymphoma.