Dose-Modified Oral Combination Chemotherapy In Patients With Aids-Related Non-Hodgkin's Lymphoma In The United States And Africa
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease response
Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
No
Scot C. Remick, MD
Study Chair
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government
CWRU2498
NCT00049439
March 1998
February 2008
Name | Location |
---|---|
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 |