Bleomycin in Treating Patients With Non-Hodgkin's Lymphoma
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma
Intervention: bleomycin (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Case Comprehensive Cancer Center Official(s) and/or principal investigator(s):
Scot C. Remick, MD, Study Chair, Affiliation: 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: Treatment
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, 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: May 23, 2008
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