Altretamine and Etoposide in Treating Patients With HIV-Related Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of altretamine plus etoposide in treating patients with HIV-related cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Hexamethylamine and VP-16 an Oral Regimin for HIV Malignancies: A Phase I/II Trial|
|Study Start Date:||July 1996|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002936
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Study Chair:||Lawrence P. Leichman, MD||Albany Medical College|