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Biological Therapy Following Chemotherapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma



Biological Therapy Following Chemotherapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

For Condition: recurrent grade 2 follicular lymphoma,recurrent grade 3 follicular lymphoma,recurrent grade 1 follicular lymphoma
Status: Recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining biological therapy with chemotherapy may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of biological therapy following chemotherapy in treating patients who have relapsed or refractorynon-Hodgkin's lymphoma.
Details: OBJECTIVES: - Assess the safety and toxicity of cellular immunotherapy with autologous CD8+ cytotoxic T lymphocyte clones following cyclophosphamide, vincristine, and prednisone in patients with relapsed or refractory CD20+ follicular non-Hodgkin's lymphoma. - Determine the duration of in vivo persistence of adoptively transferred CD20-specific CD8+ cytotoxic T lymphocyte clones in the absence and presence of subcutaneous interleukin-2 in these patients. - Assess the trafficking of CD8+ cytotoxic T lymphocyte clones to lymph nodes in these patients treated with this regimen. - Determine immune responses and tumor responses in these patients when treated with this regimen. OUTLINE: Patients undergo leukapheresis. Selected CD20-specific CD8+ cells are cultured to expand the cytotoxic T lymphocytes (CTL), which are then cloned. Patients receive oral cyclophosphamide and oral prednisone on days 1-5 and vincristine IV on day 1. Courses repeat every 3-4 weeks for a total of 6 courses. Beginning 4 weeks after the last course of chemotherapy, patients receive autologous CD8+ CTL clones IV over 30 minutes. Courses repeat every 2 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity. The last 6 patients receive interleukin-2 subcutaneously every 12 hours for 10 days, beginning 2 hours after each infusion of CD8+ CTL clones. Patients are followed at 1 month. PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study within 2 years.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Immunohistopathologically documented relapsed or refractory CD20+ follicular non-Hodgkin's lymphoma (grade I, II, or III) - Ineligible for or unwilling to participate in other FHCRC/UWMC protocols - Serological evidence of prior exposure to Epstein-Barr virus - No CNS involvement PATIENT CHARACTERISTICS: Age: - Any age Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - HIV negative - No current infection - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 months since prior rituximab - No other concurrent immunotherapy Chemotherapy: - At least 2 years since prior fludarabine or cladribine - At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: - No concurrent systemic corticosteroids except to treat toxicity from chemotherapy or cellular immunotherapy Radiotherapy: - Not specified Surgery: - Not specified Other: - At least 4 weeks since prior immunosuppressive therapy and recovered - No concurrent pentoxifylline - No other concurrent investigational agents
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
OliverPress,  Study Chair,  Fred Hutchinson Cancer Research Center

Fred Hutchinson Cancer Research Center *Recruiting*
Seattle,  Washington,  98109-1024
United States
Recruiting Oliver  Press 206-667-1872


Additional Information:
Study ID Numbers:
  CDR0000068494;  FHCRC-1503.00,NCI-G01-1921
Study Start Date: 
Record last reviewed: March 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012207

Other Recurrent Grade 1 Follicular Lymphoma Studies:
1. Radiolabeled Monoclonal Antibody in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

2. Vaccine Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma

3. Thalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

4. Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Colon Cancer, or Prostate Cancer That Has Not Responded to Vaccine Therapy

5. FR901228 Alone or Combined With Rituximab and Fludarabine in Treating Patients With Relapsed or Refractory Low-Grade B-Cell Non-Hodgkin's Lymphoma

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Biological Therapy Following Chemotherapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

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