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



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

For Condition: Lymphoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Sidney Kimmel Cancer Center
Synopsis: 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.
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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: 
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
GeorgiaVogelsang,  Study Chair,  Sidney Kimmel Cancer Center

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


Additional Information:
Study ID Numbers:  CDR0000066427;  JHOC-97080106,NCI-V98-1453,JHOC-9726
Study Start Date: October 1997
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003414

Other Lymphoma Studies:
1. Epoetin alfa in Treating Anemia in Patients Who Are Receiving Chemotherapy

2. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Advanced Hematologic Cancer

3. Darbepoetin alfa Compared With Epoetin alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer

4. Peripheral Stem Cell Transplantation Plus Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma

5. XK469 in Treating Patients With Advanced Solid Tumors or Lymphoma

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