Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021307
Status:
WITHDRAWN
Last Update Posted:
2013-07-11
First Post:
2001-07-11
Brief Title:
Temozolomide Plus Carboplatin in Treating Patients With Recurrent Glioblastoma Multiforme
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Phase III Trial Of Temozolomide And Carboplatin In Recurrent Glioblastoma Multiforme
Status:
WITHDRAWN
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study not activated
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of temozolomide plus carboplatin in treating patients who have recurrent glioblastoma multiforme
PURPOSE Phase III trial to study the effectiveness of temozolomide plus carboplatin in treating patients who have recurrent glioblastoma multiforme
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose MTD of temozolomide and carboplatin in patients with recurrent glioblastoma multiforme II Determine the toxic effects of this regimen in these patients III Determine the pharmacokinetics of this regimen in these patients IV Determine the potential of either a pharmacokinetic or pharmacodynamic-mediated drug interaction in patients treated with this regimen V Determine the objective response rate and stabilization rate in patients treated with this regimen at the MTD VI Determine the acute and long-term toxic effects of this regimen at the MTD in these patients VII Determine the time to tumor progression and survival of patients treated with this regimen
OUTLINE This is a dose-escalation study Patients are stratified according to age under 50 vs 50 and over ECOG performance status 0 vs 1-2 and prior therapy with carmustine or lomustine yes vs no Patients receive carboplatin IV over 30 minutes on day 1 and oral temozolomide on days 1-5 Treatment repeats every 4 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity Patients with stable or responsive disease may receive 6 additional courses of temozolomide Cohorts of 1-6 patients receive escalating doses of carboplatin and temozolomide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Additional patients are treated at the MTD
PROJECTED ACCRUAL Approximately 3-30 patients will be accrued for phase I of this study A total of 16-58 patients will be accrued for phase II of this study
OUTLINE This is a dose-escalation study Patients are stratified according to age under 50 vs 50 and over ECOG performance status 0 vs 1-2 and prior therapy with carmustine or lomustine yes vs no Patients receive carboplatin IV over 30 minutes on day 1 and oral temozolomide on days 1-5 Treatment repeats every 4 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity Patients with stable or responsive disease may receive 6 additional courses of temozolomide Cohorts of 1-6 patients receive escalating doses of carboplatin and temozolomide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Additional patients are treated at the MTD
PROJECTED ACCRUAL Approximately 3-30 patients will be accrued for phase I of this study A total of 16-58 patients will be accrued for phase II of 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 |
|---|---|---|---|
| NCI-G01-1981 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068768 | REGISTRY | None | None |