Trials / Completed
CompletedNCT00002936
Altretamine and Etoposide in Treating Patients With HIV-Related Cancer
Hexamethylamine and VP-16 an Oral Regimin for HIV Malignancies: A Phase I/II Trial
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Roswell Park Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | altretamine | |
| DRUG | etoposide |
Timeline
- Start date
- 1996-07-01
- Primary completion
- 2007-01-01
- First posted
- 2004-05-13
- Last updated
- 2013-02-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00002936. Inclusion in this directory is not an endorsement.