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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center Merck Northwestern University Evanston Northwestern Healthcare |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00667615 |
The purpose of this study is to replace a drug with many side effects, procarbazine, with a new novel drug, vorinostat, in a drug combination for the treatment of patients with diffuse large B-cell lymphoma. Vorinostat is the first of a new type of chemotherapy drug, known as a histone deacetylase inhibitor, to be approved by the Food and Drug Administration. It is approved for the treatment of certain lymphomas of the skin. It alters the cancer cell pathway by preventing cancer cells from reproducing. Vorinostat will be added to a combination of four other effective chemotherapy drugs that have been used for many years for the treatment of diffuse large B-cell lymphoma: rituximab, cyclophosphamide, etoposide and prednisone. The doses of vorinostat will be increased or decreased depending on the side effects that occur in each of the first few patients in the trial to find the safest dose with the least side effects. This is termed the phase I part of the clinical trial. Once the best dose of vorinostat is found, the rest of the patients in the clinical trial will be treated with this dose. This is termed the phase II part of the trial. The object of the trial is to find out what effects, good and/or bad, the combination of vorinostat, rituximab, cyclophosphamide, etoposide and prednisone will have on you and your lymphoma.
Condition | Intervention | Phase |
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Hodgkin's Disease Lymphoma |
Drug: rituximab, cyclophosphamide, etoposide, prednisone, vorinostat and QOL questionnaire, peg-filgrastim or filgrastim |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Trial of Vorinostat in Combination With Cyclophosphamide, Etoposide, Prednisone and Rituximab for Elderly Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL) |
Estimated Enrollment: | 59 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
vorinostat in combination with cyclophosphamide, etoposide,prednisone and rituximab,peg-filgrastim or filgrastim
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Drug: rituximab, cyclophosphamide, etoposide, prednisone, vorinostat and QOL questionnaire, peg-filgrastim or filgrastim
Patients will be treated with 6 cycles of rituximab, cyclophosphamide, etoposide, prednisone and vorinostat every 4 weeks. Quality of life determinations will be obtained at the beginning of each cycle of chemotherapy and at each visit during the first year of followup.
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Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David Straus, MD | strausd@mskcc.org | |
Contact: Paul Hamlin, MD | hamlinp@mskcc.org |
United States, New Jersey | |
Memorial Sloan-Kettering Cancer Center @ BaskingRidge | Recruiting |
Basking Ridge, New Jersey, United States, 07920 | |
Contact: David Straus, MD | |
Principal Investigator: David Straus, MD | |
United States, New York | |
Memorial Sloan Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: David Straus, MD strausd@mskcc.org | |
Contact: Paul Hamlin, MD hamlinp@mskcc.org | |
Principal Investigator: David Straus, MD | |
Memorial Sloan-Kettering Cancer Center @ Suffolk | Recruiting |
Commack, New York, United States, 11725 | |
Contact: David Straus, MD strausd@mskcc.org | |
Contact: Paul Hamlin, MD hamlinp@mskcc.org | |
Principal Investigator: David Straus, MD | |
Memorial Sloan-Kettering Cancer Center @ Phelps | Recruiting |
Sleepy Hollow, New York, United States, 10591 | |
Contact: David Straus, MD strausd@mskcc.org | |
Principal Investigator: David Straus, MD |
Principal Investigator: | David Straus, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( David Straus ) |
Study ID Numbers: | 08-045 |
Study First Received: | April 24, 2008 |
Last Updated: | September 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00667615 |
Health Authority: | United States: Institutional Review Board |
vorinostat rituximab cyclophosphamide |
etoposide prednisone Quality of life |
Prednisone Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Hodgkin's disease Rituximab Hodgkin lymphoma, adult Vorinostat Quality of Life Cyclophosphamide Etoposide phosphate |
Lymphoma, B-Cell Lymphoma, large-cell Lymphatic Diseases B-cell lymphomas Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Etoposide Lymphoma Hodgkin Disease |
Anticarcinogenic Agents Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Alkylating Agents Neoplasms by Histologic Type Immune System Diseases |
Antineoplastic Agents, Hormonal Enzyme Inhibitors Protective Agents Immunosuppressive Agents Glucocorticoids Pharmacologic Actions Neoplasms Analgesics, Non-Narcotic Myeloablative Agonists Antineoplastic Agents, Alkylating Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Antineoplastic Agents, Phytogenic |