Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015899
Status:
COMPLETED
Last Update Posted:
2009-10-14
First Post:
2001-05-06
Brief Title:
SCH 66336 in Treating Children With Recurrent or Progressive Brain Tumors
Sponsor:
Pediatric Brain Tumor Consortium
Organization:
Pediatric Brain Tumor Consortium
Study Overview
Official Title:
Phase I Trial Of Escalating Oral Doses Of SCH 66336 In Pediatric Patients With Refractory Or Recurrent Brain Tumors
Status:
COMPLETED
Status Verified Date:
2009-10
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 SCH 66336 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth
PURPOSE This phase I trial is studying the side effects and best dose of SCH 66336 in treating children with recurrent or progressive brain tumors
PURPOSE This phase I trial is studying the side effects and best dose of SCH 66336 in treating children with recurrent or progressive brain tumors
Detailed Description:
OBJECTIVES
Determine the qualitative and quantitative toxicity of SCH 66336 in children with recurrent or progressive brain tumors
Estimate the maximum tolerated dose of this drug in these patients
Describe the pharmacokinetics of this drug with and without dexamethasone in these patients
Investigate the efficacy of this drug in these patients
OUTLINE This is a dose-escalation study
Patients receive oral SCH 66336 twice daily Treatment repeats every 4 weeks for a total of 26 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 1-6 patients receive escalating doses of SCH 66336 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which it is predicted that 20 of patients may experience dose-limiting toxicity An additional 6 patients are treated at the determined MTD
Patients are followed within 30 days of the last administration of the study drug and then for up to 3 months
PROJECTED ACCRUAL Approximately 25 patients will be accrued for this study
Determine the qualitative and quantitative toxicity of SCH 66336 in children with recurrent or progressive brain tumors
Estimate the maximum tolerated dose of this drug in these patients
Describe the pharmacokinetics of this drug with and without dexamethasone in these patients
Investigate the efficacy of this drug in these patients
OUTLINE This is a dose-escalation study
Patients receive oral SCH 66336 twice daily Treatment repeats every 4 weeks for a total of 26 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 1-6 patients receive escalating doses of SCH 66336 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which it is predicted that 20 of patients may experience dose-limiting toxicity An additional 6 patients are treated at the determined MTD
Patients are followed within 30 days of the last administration of the study drug and then for up to 3 months
PROJECTED ACCRUAL Approximately 25 patients 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 |
|---|---|---|---|
| SPRI-P02201 | None | None | None |
| PBTC-003 | None | None | None |