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



Status:Completed
Conditions:Lymphoma, Orthopedic, Hematology
Therapuetic Areas:Hematology, Oncology, Orthopedics / Podiatry
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:October 1997
End Date:May 2004

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Randomized Trial of Autologous GVHD for Refractory Lymphoma

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
.

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.

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
We found this trial at
1
site
Baltimore, Maryland 21231
410-955-6190
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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from
Baltimore, MD
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