Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087061
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2004-07-08
Brief Title:
Gimatecan in Treating Patients With Recurrent or Progressive Primary Malignant Glioma
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Oral ST1481 in Adults With Malignant Glioma A Phase I-II Clinical Trial
Status:
COMPLETED
Status Verified Date:
2005-05
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 such as gimatecan work in different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE This phase III trial is studying the side effects and best dose of gimatecan in treating patients with recurrent or progressive primary malignant glioma
PURPOSE This phase III trial is studying the side effects and best dose of gimatecan in treating patients with recurrent or progressive primary malignant glioma
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose MTD of gimatecan in patients with recurrent or progressive primary malignant glioma treated with or without concurrent enzyme-inducing anticonvulsant drugs
Determine whether this drug has sufficient activity to warrant further development in these patients phase II
Secondary
Determine the qualitative and quantitative toxic effects of this drug in these patients
Determine the pharmacokinetic behaviors of this drug in these patients
Correlate the principal toxic effects with the pertinent pharmacokinetic parameters of this drug in these patients
Determine the antitumor activity of this drug in these patients
OUTLINE This is an open-label dose-escalation multicenter study Patients are stratified according to the concurrent use of enzyme-inducing anticonvulsant drugs yes vs no
Phase I Patients receive oral gimatecan once daily on days 1-5 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of gimatecan 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
Phase II Patients receive gimatecan as in phase I at the MTD Patients are followed for at least 1 month and then every 2 months thereafter
PROJECTED ACCRUAL Approximately 30-83 patients 30-42 for phase I 15-21 per stratum and 21-41 for phase II will be accrued for this study within 24 months
Primary
Determine the maximum tolerated dose MTD of gimatecan in patients with recurrent or progressive primary malignant glioma treated with or without concurrent enzyme-inducing anticonvulsant drugs
Determine whether this drug has sufficient activity to warrant further development in these patients phase II
Secondary
Determine the qualitative and quantitative toxic effects of this drug in these patients
Determine the pharmacokinetic behaviors of this drug in these patients
Correlate the principal toxic effects with the pertinent pharmacokinetic parameters of this drug in these patients
Determine the antitumor activity of this drug in these patients
OUTLINE This is an open-label dose-escalation multicenter study Patients are stratified according to the concurrent use of enzyme-inducing anticonvulsant drugs yes vs no
Phase I Patients receive oral gimatecan once daily on days 1-5 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of gimatecan 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
Phase II Patients receive gimatecan as in phase I at the MTD Patients are followed for at least 1 month and then every 2 months thereafter
PROJECTED ACCRUAL Approximately 30-83 patients 30-42 for phase I 15-21 per stratum and 21-41 for phase II will be accrued for this study within 24 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCLA-0403029-01 | None | None | None |
| SIGMATAU-ST-01-402 | None | None | None |