Combination Chemotherapy in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Registration Number
- NCT00049439
- Lead Sponsor
- Case Comprehensive Cancer Center
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining lomustine, etoposide, cyclophosphamide, and procarbazine in treating patients who have AIDS-related non-Hodgkin's lymphoma.
- Detailed Description
OBJECTIVES:
* Determine the objective response rate, response duration, and survival of patients with AIDS-related non-Hodgkin's lymphoma treated with lomustine, etoposide, cyclophosphamide, and procarbazine.
* Determine the feasibility of this regimen in these patients.
* Determine the clinical toxicity of this regimen in these patients.
* Assess the quality of life of patients treated with this regimen.
* Determine the impact of this regimen on the underlying HIV infection in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral lomustine on day 1 (course 1 only), oral etoposide on days 1-3, and oral cyclophosphamide and oral procarbazine on days 22-26. Patients may also receive filgrastim (G-CSF) subcutaneously on days 5-21 and 28-42. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, on days 1 and 22 of each course, at day 84, and then every 3 months for 1 year.
Patients are followed at day 84 and then every 3 months.
PROJECTED ACCRUAL: A total of 66 patients (22 in the United States and 44 in Africa) will be accrued for this study within 3-4 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Disease response Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
- Secondary Outcome Measures
Name Time Method Quality of life as assessed by the Functional Living Index-Cancer and the Brief Symptom Inventory days 1 and 2 of courses 1 and 2 and on day 84
Trial Locations
- Locations (4)
Uganda Cancer Institute
🇺🇬Kampala, Uganda
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States
University of Nairobi College of Health Sciences
🇰🇪Nairobi, Kenya
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States