Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006247
Status:
TERMINATED
Last Update Posted:
2009-10-14
First Post:
2000-09-11
Brief Title:
SU5416 in Treating Children With Recurrent or Progressive Brain Tumors
Sponsor:
Pediatric Brain Tumor Consortium
Organization:
Pediatric Brain Tumor Consortium
Study Overview
Official Title:
A Phase I Study of SU5416 in Pediatric Patients With Recurrent or Progressive Poor Prognosis Brain Tumors
Status:
TERMINATED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The pharmaceutical company discontinued further development of SU5416
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE SU5416 may stop the growth of brain cancer cells by stopping blood flow to the tumor
PURPOSE Phase I trial to study the safety of delivering SU5416 in children who have recurrent or progressive brain tumors
PURPOSE Phase I trial to study the safety of delivering SU5416 in children who have recurrent or progressive brain tumors
Detailed Description:
OBJECTIVES I Determine the qualitative and quantitative toxicity of SU5416 in pediatric patients with recurrent or progressive brain tumors II Determine the acute and chronic dose-limiting toxicity and cumulative toxicity of this regimen in these patients III Determine the maximum tolerated dose and pharmacokinetics of this regimen in this patient population IV Determine the effects of hepatic enzyme-inducing drugs such as anticonvulsant agents on the pharmacokinetics of this regimen in these patients V Determine the efficacy in a preliminary manner of this regimen in these patients
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to concurrent use of enzyme-inducing anticonvulsant drugs yes vs no drugs or modest-induction drugs Patients receive SU5416 IV over 1 hour twice a week for 6 weeks Treatment repeats every 6 weeks for 17 courses approximately 2 years in the absence of unacceptable toxicity or disease progression Cohorts of 3-6 patients in each stratum receive escalating doses of SU5416 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 toxicity Patients are followed every 3 months for 1 year every 6 months for 4 years and then annually for 5 years
PROJECTED ACCRUAL A total of 50 patients 25 per stratum will be accrued for this study
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to concurrent use of enzyme-inducing anticonvulsant drugs yes vs no drugs or modest-induction drugs Patients receive SU5416 IV over 1 hour twice a week for 6 weeks Treatment repeats every 6 weeks for 17 courses approximately 2 years in the absence of unacceptable toxicity or disease progression Cohorts of 3-6 patients in each stratum receive escalating doses of SU5416 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 toxicity Patients are followed every 3 months for 1 year every 6 months for 4 years and then annually for 5 years
PROJECTED ACCRUAL A total of 50 patients 25 per stratum will be accrued for this study
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 |
|---|---|---|---|
| PBTC-002 | None | None | None |