Dose-Modified Oral Combination Chemotherapy In Patients With Aids-Related Non-Hodgkin's Lymphoma In The United States And Africa
- 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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Scot C. Remick, MD
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|Herbert Irving Comprehensive Cancer Center at Columbia University||New York, New York 10032|