Lymphoma Clinical Trial
Official title:
A Phase II Trial of 72-Hour Continuous Infusion Bleomycin as Salvage Therapy in AIDS-Related and Immunocompetent Non-Hodgkin's Lymphoma
Verified date | June 2010 |
Source | Case Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5 |
Est. completion date | December 2002 |
Est. primary completion date | August 2001 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Comprehensive Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The effectiveness of bleomycin in treating patients with non-Hodgkin's lymphoma. | 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. | No |
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