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Dose-Modified Oral Combination Chemotherapy In Patients With Aids-Related Non-Hodgkin's Lymphoma In The United States And Africa
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.
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.
Age
16 - No limit years
Sex
ALL
Healthy Volunteers
No
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
University of Nairobi College of Health Sciences
Nairobi, Kenya
Uganda Cancer Institute
Kampala, Uganda
Start Date
March 1, 1998
Primary Completion Date
October 1, 2005
Completion Date
February 1, 2008
Last Updated
June 11, 2010
54
ACTUAL participants
filgrastim
BIOLOGICAL
cyclophosphamide
DRUG
etoposide
DRUG
lomustine
DRUG
procarbazine hydrochloride
DRUG
Lead Sponsor
Case Comprehensive Cancer Center
Collaborators
NCT07388563
NCT05529069
Data Source & Attribution
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