Hexamethylamine and VP-16 an Oral Regimin for HIV Malignancies: A Phase I/II Trial
OBJECTIVES: I. Determine toxic effects of repeated courses of altretamine plus etoposide at
the maximum tolerated dose (MTD). II. Assess the response duration and time to progression
at the MTD in the treatment of HIV malignancies. III. Assess the efficacy of the combination
on the immune systems of these individuals. IV. Assess the effect of the combination on the
quality of life in these individuals.
OUTLINE: Patients are treated with altretamine (HMM) and etoposide for 2 weeks followed by 2
weeks of rest. This cycle is repeated for a minimum of 2 and a maximum of 6 cycles if there
is no progression of disease. Patients who are in complete remission receive an additional 2
cycles (total of 8 cycles). There are different cohorts consisting of 4 patients each in
which toxic effects will be evaluated with escalating doses of this combination. The MTD is
defined as the dose level immediately below that at which half of the patients experience
dose-limiting toxicity. Patients are followed for relapse and survival.
PROJECTED ACCRUAL: 20 patients will be accrued in 2 years.
Primary Purpose: Treatment
Lawrence P. Leichman, MD
Albany Medical College
United States: Federal Government
|Roswell Park Cancer Institute||Buffalo, New York 14263|