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| Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003414 |
Purpose
RATIONALE: Cyclosporine may induce graft-versus-host disease and make the body build an immune response that will kill cancer cells. Interleukin-2 and interferon gamma may enhance the effectiveness of graft-versus-host disease to kill cancer cells.
PURPOSE: Randomized phase III trial to determine the effectiveness of graft-versus-host disease in treating patients who have recurrent or refractory lymphoma or Hodgkin's disease .
| Condition | Intervention | Phase |
|---|---|---|
|
Graft Versus Host Disease Lymphoma |
Biological: aldesleukin Biological: recombinant interferon gamma Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | Randomized Trial of Autologous GVHD for Refractory Lymphoma |
| Estimated Enrollment: | 50 |
| Study Start Date: | October 1997 |
OBJECTIVES: I. Determine whether autologous graft versus host disease significantly alters the relapse rate for lymphoma or Hodgkin's disease after autologous bone marrow transplantation.
OUTLINE: This is a randomized study. Stem cells are harvested and cryopreserved. All patients receive busulfan/cyclophosphamide or cyclosporine/total body irradiation as a preparative regimen. Arm I: Patients randomized to the graft versus host disease (GVHD) induction arm receive oral cyclosporine twice a day beginning on day 0 and continuing for at least 28 days, followed by peripheral blood stem cell (PBSC) infusion. At the time the white blood cell count begins to recover, subcutaneous interferon gamma is administered for 10 doses, followed 2 days later by subcutaneous interleukin-2 (IL-2) for 18 doses. Arm II: Patients do not receive autologous GVHD therapy after the PBSC transplant. Both arms should receive radiation to the site of lymphoma after recovering from the stem cell transplantation. Patients are followed at 6 months, 1 year, and 2 years posttransplant.
PROJECTED ACCRUAL: Approximately 50 patients (25 per arm) will be accrued for this study within 3 years.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Patients receiving autologous or syngeneic peripheral blood stem cell transplants for chemotherapy refractory or recurrent lymphoma or Hodgkin's disease, including: Progressive disease within 6 weeks of completing initial induction therapy OR Failure to achieve at least an overall partial response (at least a 50% reduction in tumor size) to conventional salvage therapy following relapse
PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy: Not specified Hematopoietic: No capillary leak syndrome Hepatic: Bilirubin no greater than 5 mg/dL Renal: Creatinine less than 4 mg/dL No renal failure requiring dialysis Cardiovascular: No hypotension No severe venooclusive disease Pulmonary: No pulmonary infiltrates OR No requirement for greater than 2 L oxygen Other: No weight gain greater than 5% of baseline weight No concurrent sepsis No temperature of 39 degrees C or higher for two or more days No clinically evident ascites
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Prior chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Contacts and Locations| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| Study Chair: | Georgia B. Vogelsang, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000066427, JHOC-97080106, JHOC-9726, NCI-V98-1453 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003414 History of Changes |
| Health Authority: | United States: Federal Government |
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recurrent adult Hodgkin lymphoma recurrent childhood lymphoblastic lymphoma recurrent/refractory childhood Hodgkin lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma |
recurrent adult Burkitt lymphoma graft versus host disease recurrent childhood small noncleaved cell lymphoma recurrent childhood large cell lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma |
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Cyclosporine Interferon Type II Lymphoma, Mantle-Cell Mantle Cell Lymphoma Follicular Lymphoma Cyclosporins Graft Versus Host Disease Leukemia, Lymphocytic, Chronic, B-Cell Hodgkin Disease Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Anti-HIV Agents Aldesleukin B-cell Lymphomas Lymphoma, Non-Hodgkin |
Interferon-gamma, Recombinant Immunologic Factors Hodgkin Lymphoma, Childhood Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Cyclophosphamide Lymphoblastic Lymphoma Lymphoma, Large-cell, Immunoblastic Lymphoma, Small Cleaved-cell, Diffuse Lymphoma, B-Cell Anti-Retroviral Agents Antifungal Agents Lymphoma, Large-Cell, Immunoblastic Leukemia, B-cell, Chronic Lymphoma, Large-cell |
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Anti-Infective Agents Cyclosporine Interferon Type II Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Cyclosporins Anti-Retroviral Agents Antifungal Agents Therapeutic Uses Dermatologic Agents Lymphoma Alkylating Agents |
Anti-HIV Agents Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Interferons Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Aldesleukin Myeloablative Agonists Graft vs Host Disease Antineoplastic Agents, Alkylating |
