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


Phase 2
N/A
N/A
Not Enrolling
Both
Lymphoma

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome 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.

Safety Issue:

No

Principal Investigator

Scot C. Remick, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CWRU5496

NCT ID:

NCT00003110

Start Date:

July 1997

Completion Date:

December 2002

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065