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Bleomycin in Treating Patients With Non-Hodgkin's Lymphoma

Information source: Case Comprehensive Cancer Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma

Intervention: bleomycin sulfate (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: Case Comprehensive Cancer Center

Official(s) and/or principal investigator(s):
Scot C. Remick, MD, Principal Investigator, Affiliation: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Summary

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.

Clinical Details

Official title: A Phase II Trial of 72-Hour Continuous Infusion Bleomycin as Salvage Therapy in AIDS-Related and Immunocompetent Non-Hodgkin's Lymphoma

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The effectiveness of bleomycin in treating patients with non-Hodgkin's lymphoma.

Detailed description: 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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center, Cleveland, Ohio 44106-5065, United States
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: July 1997
Last updated: June 10, 2010

Page last updated: August 20, 2015

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