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| Tracking Information | |||||
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| First Received Date ICMJE | November 1, 1999 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | October 1997 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00003414 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Graft-Versus-Host Disease in Treating Patients With Recurrent or Refractory Lymphoma or Hodgkin's Disease | ||||
| Official Title ICMJE | Randomized Trial of Autologous GVHD for Refractory Lymphoma | ||||
| Brief Summary | 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 . |
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| Detailed Description | 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. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | Bolanos-Meade J, Garrett-Mayer E, Luznik L, Anders V, Webb J, Fuchs EJ, Huff CA, Matsui W, Borrello IM, Brodsky R, Kasamon YL, Swinnen LJ, Flinn IW, Ambinder RF, Jones RJ, Hess AD, Vogelsang GB. Induction of Autologous Graft-versus-Host Disease: Results of a Randomized Prospective Clinical Trial in Patients with Poor Risk Lymphoma. Biol Blood Marrow Transplant. 2007 Oct;13(10):1185-91. Epub 2007 Aug 3. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00003414 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000066427, JHOC-97080106, JHOC-9726, NCI-V98-1453 | ||||
| Study Sponsor ICMJE | Sidney Kimmel Comprehensive Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | September 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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