Bleomycin in Treating Patients With Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00003110
First received: November 1, 1999
Last updated: June 10, 2010
Last verified: June 2010
  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.


Condition Intervention Phase
Lymphoma
Biological: bleomycin sulfate
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of 72-Hour Continuous Infusion Bleomycin as Salvage Therapy in AIDS-Related and Immunocompetent Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • The effectiveness of bleomycin in treating patients with non-Hodgkin's lymphoma. [ Time Frame: Continuous infusion for 72 hours every 3 weeks. Induction therapy consists of 3 cycles. Patients who achieve CR receive 2 more cycles. Patients with PR or stable disease may continue therapy until disease progression or unacceptable toxicity occurs. ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: July 1997
Study Completion Date: December 2002
Primary Completion Date: August 2001 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: bleomycin sulfate
    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.
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00003110

Locations
United States, Ohio
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Scot C. Remick, MD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Scot C. Remick, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00003110     History of Changes
Other Study ID Numbers: CWRU5496, P30CA043703, CWRU-5496, AMC-7A-94, BMS-CWRU-5496, NCI-G97-1343
Study First Received: November 1, 1999
Last Updated: June 10, 2010
Health Authority: United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:
recurrent childhood lymphoblastic lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
AIDS-related peripheral/systemic lymphoma
AIDS-related diffuse large cell lymphoma
AIDS-related immunoblastic large cell lymphoma
AIDS-related small noncleaved cell lymphoma
AIDS-related diffuse mixed cell lymphoma
AIDS-related diffuse small cleaved cell lymphoma
AIDS-related lymphoblastic lymphoma
recurrent childhood small noncleaved cell lymphoma
recurrent childhood large cell lymphoma
recurrent mantle cell lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bleomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014