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	Treatment or Intervention	Phase
Lymphoma	Procedure: chemotherapy  Procedure: biological response modifier therapy  Procedure: radiation therapy  Procedure: graft versus host disease prophylaxis/therapy  Procedure: interferon therapy  Behavior: supportive care/therapy  Procedure: peripheral blood stem cell transplantation  Procedure: cytokine therapy  Procedure: interleukin therapy  Drug: bone marrow ablation with stem cell support  Drug: busulfan  Drug: cyclophosphamide  Drug: cyclosporine  Drug: interferon gamma  Drug: interleukin-2	Phase III

Further Study Details: 

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.

PROTOCOL 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.

Criteria

PROTOCOL ENTRY 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

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: See Disease Characteristics; Prior chemotherapy allowed
• Endocrine therapy: Not specified
• Radiotherapy: Not specified
• Surgery: Not specified

--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

Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231-2410,  United States

Study chairs or principal investigators

Georgia B. Vogelsang,  Study Chair,  Sidney Kimmel Cancer Center   

Study ID Numbers:  CDR0000066427; JHOC-97080106; NCI-V98-1453; JHOC-9726
Record last reviewed:  December 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003414
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08