Expired Study
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Cleveland, Ohio 44106


Purpose:

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.


Study summary:

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. 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.


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. 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 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


NCT ID:

NCT00003110


Primary Contact:

Principal Investigator
Scot C. Remick, MD
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44106
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 23, 2017

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