Randomized Trial of Autologous GVHD for Refractory Lymphoma
aldesleukin
+ recombinant interferon gamma
+ busulfan
Chronic Disease+35
+ DNA Virus Infections
+ Hematologic Diseases
Treatment Study
Summary
Study start date: October 1, 1997
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, United StatesOpen Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Google Maps