Graft-Versus-Host Disease in Treating Patients With Recurrent or Refractory Lymphoma or Hodgkin's Disease

Johns Hopkins Medicine

Status and phase: Completed; Phase 3

Conditions: Graft Versus Host Disease; Lymphoma

Treatments: Drug: cyclophosphamide; Drug: busulfan; Procedure: peripheral blood stem cell transplantation; Radiation: radiation therapy; Drug: cyclosporine; Biological: recombinant interferon gamma; Biological: aldesleukin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00003414

NCI-V98-1453

JHOC-9726

P30CA006973 (U.S. NIH Grant/Contract)

JHOC-97080106

P01CA015396 (U.S. NIH Grant/Contract)

J9726 CDR0000066427

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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