Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024024
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2001-09-13
Brief Title:
BMS-275291 in Treating Patients With HIV-Related Kaposis Sarcoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I-II Trial Of BMS-275291 In Patients With HIV-Related Kaposis Sarcoma
Status:
COMPLETED
Status Verified Date:
2008-04
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:
Phase III trial to study the effectiveness of BMS-275291 in treating patients who have HIV-related Kaposis sarcoma Drugs such as BMS-275291 may stop the growth of Kaposis sarcoma by stopping blood flow to the tumor
Detailed Description:
OBJECTIVES
I Determine whether the change in percent of apoptotic cells on tumor biopsies before and after treatment with BMS-275291 is a valid endpoint in patients with HIV-related Kaposis sarcoma
II Determine the safety and tolerability of this drug in these patients III Determine the antitumor effects of this drug in these patients IV Determine the effect of this drug on overall quality of life and tumor-specific symptoms in these patients
V Determine the effect of this drug on CD4 and CD8 cell counts and percentages and HIV viral load in these patients
VI Determine the effect of this drug on human herpes virus-8 HHV-8 viral load and correlate HHV-8 viral burden tumor stage and prognosis in these patients
VII Determine the peak plasma concentration of this drug in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive oral BMS-275291 1-2 times daily Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 6 patients receive escalating doses of BMS-275291 until the recommended phase II dose RPTD is determined The RPTD is the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity and more than 1 of 6 patients experiences clinical response or at least 5 of 6 patients demonstrate biologic activity An additional 29 patients are treated at the RPTD
Quality of life is assessed on day 15 of the first course and then every 28 days thereafter
Patients are followed for at least 1 month
I Determine whether the change in percent of apoptotic cells on tumor biopsies before and after treatment with BMS-275291 is a valid endpoint in patients with HIV-related Kaposis sarcoma
II Determine the safety and tolerability of this drug in these patients III Determine the antitumor effects of this drug in these patients IV Determine the effect of this drug on overall quality of life and tumor-specific symptoms in these patients
V Determine the effect of this drug on CD4 and CD8 cell counts and percentages and HIV viral load in these patients
VI Determine the effect of this drug on human herpes virus-8 HHV-8 viral load and correlate HHV-8 viral burden tumor stage and prognosis in these patients
VII Determine the peak plasma concentration of this drug in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive oral BMS-275291 1-2 times daily Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 6 patients receive escalating doses of BMS-275291 until the recommended phase II dose RPTD is determined The RPTD is the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity and more than 1 of 6 patients experiences clinical response or at least 5 of 6 patients demonstrate biologic activity An additional 29 patients are treated at the RPTD
Quality of life is assessed on day 15 of the first course and then every 28 days thereafter
Patients are followed for at least 1 month
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 |
|---|---|---|---|
| AMC-024 | None | None | None |
| CPMC-IRB-13985 | None | None | None |
| CDR0000068885 | REGISTRY | PDQ Physician Data Query | None |