Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006463
Status:
COMPLETED
Last Update Posted:
2014-02-21
First Post:
2000-11-06
Brief Title:
Ecteinascidin 743 in Treating Children With Refractory Solid Tumors
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Phase I Study of ET-743 in Pediatric Refractory Solid Tumors
Status:
COMPLETED
Status Verified Date:
2014-02
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 Ecteinascidin 743 may be an effective treatment for solid tumors
PURPOSE Phase I trial to study the effectiveness of ecteinascidin 743 in treating children who have refractory solid tumors
PURPOSE Phase I trial to study the effectiveness of ecteinascidin 743 in treating children who have refractory solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and dose-limiting toxicity of ecteinascidin 743 in pediatric patients with refractory solid tumors II Determine the pharmacokinetics of this drug in these patients III Determine the antitumor activity of this drug in this patient population
OUTLINE This is a dose escalation multicenter study Patients are stratified according to pretreatment pretreated vs less heavily pretreated Patients receive ecteinascidin 743 IV over 3 hours on day 1 Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of ecteinascidin 743 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicities
PROJECTED ACCRUAL A total of 3-20 patients will be accrued for this study within 2 years
OUTLINE This is a dose escalation multicenter study Patients are stratified according to pretreatment pretreated vs less heavily pretreated Patients receive ecteinascidin 743 IV over 3 hours on day 1 Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of ecteinascidin 743 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicities
PROJECTED ACCRUAL A total of 3-20 patients will be accrued for this study within 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 |
|---|---|---|---|
| CDR0000068273 | OTHER | Clinical Trialsgov | None |
| COG-P9972 | OTHER | None | None |
| POG-P9972 | OTHER | None | None |