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Home > "B" Clinical Trials Conditions > Bleomycin in Treating Patients With Non-Hodgkin's Lymphoma  Bleomycin in Treating Patients With Non-Hodgkin's Lymphoma
Bleomycin in Treating Patients With Non-Hodgkin's Lymphoma
For Condition: Lymphoma
Status: No longer recruiting
Sponsor(s): Ireland Cancer Center ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of bleomycin in treating patients with non-Hodgkin's lymphoma.
Details: OBJECTIVES: I. Determine the objective response rate, response duration and survival of patients receiving bleomycin as salvage therapy for AIDS-related or immunocompetent non-Hodgkin's lymphoma. II. Assess the feasibility and toxicity of treatment for this disease. III. Evaluate the quality of life of AIDS and non-AIDS patients with non-Hodgkin's lymphoma. PROTOCOL OUTLINE: Patients are stratified by number of prior cytotoxic chemotherapy regimens, prior radiotherapy, and HIV/AIDS status. Patients receive bleomycin by continuous infusion for 72 hours every 3 weeks. Induction therapy consists of 3 cycles. Patients who achieve complete remission receive 2 more cycles. Patients with partial remission or stable disease may continue therapy until disease progression or unacceptable toxicity occurs. Quality of life assessments are conducted at beginning of therapy, every 3 weeks, and at completion of treatment. Patients are followed every 3 months for overall survival. PROJECTED ACCRUAL: A total of 32 patients will be accrued.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed recurrent intermediate or high grade non-Hodgkin's lymphoma (NHL) - AIDS-related NHL eligible - At least 1 evaluable or measurable disease as defined by the following: Radiographic findings are acceptable; Bidimensionally measurable defect on a computed tomographic (CT) scan; Clearly defined abdominal masses on CT scans; Enlarged spleen and/or liver extending at least 5 cm below the costal margin; Biopsy proven lymphomatous hepatic involvement - No clinical or radiographic evidence of parenchymal CNS involvement by lymphoma (meningeal lymphoma permitted) [A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.] --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: At least 1 prior systemic chemotherapy regimen - Endocrine therapy: Not specified - Radiotherapy: Prior radiation therapy for localized stage I/II disease that has progressed beyond initial radiation therapy port is allowed - Surgery: Not specified - Other: Concurrent zidovudine, didanosine, or zalcitabine therapy allowed --Patient Characteristics-- - Age: Any age - Performance status: ECOG 0-3 - Life expectancy: At least 6 weeks - Hematopoietic: WBC at least 1500/mm3; Platelet count at least 50,000/mm3 - Hepatic: Bilirubin no greater than 3.0 mg/dL - Renal: Creatinine no greater than 3.0 mg/dL - Other: May be HIV positive; Immunocompetent (HIV-seronegative) NHL patients must be suitable candidates for bleomycin chemotherapy; Active infections undergoing drug treatment allowed; Negative head CT/MRI scan
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ScotRemick, Study Chair, Ireland Cancer Center
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Additional Information:
Study ID Numbers: CDR0000065853; CWRU-5496,NCI-G97-1343,AMC-7A-94,BMS-CWRU-5496
Study Start Date: July 1997
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003110
Other Lymphoma Studies:
1. Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer
2. Donor Stem Cell Transplantation in Treating Patients With Relapsed Hematologic Cancer
3. BMS-247550 in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction
4. Campath-1H and EPOCH to Treat non-Hodgkin's T- and NK-Cell Lymphomas
5. Comparison of Nutritional Supplements in Preventing Weight Loss in Patients With Cancer
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Bleomycin in Treating Patients With Non-Hodgkin's Lymphoma
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