Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002936
Status:
COMPLETED
Last Update Posted:
2013-02-04
First Post:
1999-11-01
Brief Title:
Altretamine and Etoposide in Treating Patients With HIV-Related Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Hexamethylamine and VP-16 an Oral Regimin for HIV Malignancies A Phase III Trial
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G97-1165 | None | None | None |
| RPCI-DS-95-05 | None | None | None |