Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00079404
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2004-03-08
Brief Title:
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of 17-AAG in RelapsedRefractory Pediatric Patients With Solid Tumors or Leukemia
Status:
COMPLETED
Status Verified Date:
2013-06
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:
This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin in treating young patients with relapsed or refractory solid tumors or leukemia Drugs used in chemotherapy such as 17-N-allylamino-17-demethoxygeldanamycin work in different ways to stop cancer cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I To estimate the maximum tolerated dose MTD and recommended phase II dose of 17-AAG administered as a 60 or 120-minute intravenous infusion on days 1 4 8 and 11 of a 21-day course to children with refractory solid tumors or relapsed leukemia
II To define and describe the toxicities of 17-AAG administered on this schedule
III To characterize the pharmacokinetics of 17-AAG in children with refractory cancer
SECONDARY OBJECTIVES
I To preliminarily define the antitumor activity of 17-AAG within the confines of a phase I study
II To assess the biologic activity of 17-AAG III To examine the role of CYP3A5 polymorphisms in the pharmacologic and clinical phenotypes observed following administration of 17-AAG to children within the confines of a phase 1 study
OUTLINE This is a dose-escalation multicenter study
Patients with solid tumors receive 17-N-allylamino-17-demethoxygeldanamycin 17-AAG IV over 60-120 minutes on days 1 4 8 and 11 Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of 17-AAG until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined up to 6 additional patients with leukemia receive 17-AAG at the MTD as above If these 6 patients tolerate this regimen another 6 leukemia patients receive 17-AAG IV over 60 minutes on days 1 4 8 11 15 and 18
Treatment repeats every 28 days for 17 courses in the absence of disease progression or unacceptable toxicity Patients are followed at 30 days
I To estimate the maximum tolerated dose MTD and recommended phase II dose of 17-AAG administered as a 60 or 120-minute intravenous infusion on days 1 4 8 and 11 of a 21-day course to children with refractory solid tumors or relapsed leukemia
II To define and describe the toxicities of 17-AAG administered on this schedule
III To characterize the pharmacokinetics of 17-AAG in children with refractory cancer
SECONDARY OBJECTIVES
I To preliminarily define the antitumor activity of 17-AAG within the confines of a phase I study
II To assess the biologic activity of 17-AAG III To examine the role of CYP3A5 polymorphisms in the pharmacologic and clinical phenotypes observed following administration of 17-AAG to children within the confines of a phase 1 study
OUTLINE This is a dose-escalation multicenter study
Patients with solid tumors receive 17-N-allylamino-17-demethoxygeldanamycin 17-AAG IV over 60-120 minutes on days 1 4 8 and 11 Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of 17-AAG until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined up to 6 additional patients with leukemia receive 17-AAG at the MTD as above If these 6 patients tolerate this regimen another 6 leukemia patients receive 17-AAG IV over 60 minutes on days 1 4 8 11 15 and 18
Treatment repeats every 28 days for 17 courses in the absence of disease progression or unacceptable toxicity Patients are followed at 30 days
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 |
|---|---|---|---|
| U01CA097452 | NIH | None | httpsreporternihgovquickSearchU01CA097452 |
| ADVL0316 | None | None | None |
| CDR0000355714 | None | None | None |
| COG-ADVL0316 | None | None | None |