Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014105
Status:
UNKNOWN
Last Update Posted:
2013-12-04
First Post:
2001-04-10
Brief Title:
Combination Chemotherapy in Treating Patients With Recurrent Glioblastoma Multiforme
Sponsor:
Atlantic Health System
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Trial of Temozolomide and Carboplatin in Recurrent Glioblastoma Multiforme
Status:
UNKNOWN
Status Verified Date:
2002-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy in treating patients who have recurrent glioblastoma multiforme
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy 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 acute and long-term 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 in patients treated with the established MTD of this regimen VI Determine time to tumor progression and survival in patients treated with this regimen
OUTLINE This is a dose-escalation study Patients are stratified according to prior nitrosourea-based chemotherapy yes vs no Patients receive carboplatin IV over 30 minutes on day 1 and oral temozolomide once daily on days 1-5 Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity Patients with a persistent response may continue to receive temozolomide only for an additional 6 courses Cohorts of 3-6 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 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are accrued to receive carboplatin and temozolomide at the recommended phase II dose
PROJECTED ACCRUAL A total of 13-70 patients 3-30 for phase I and 10-40 for phase II will be accrued for this study
OUTLINE This is a dose-escalation study Patients are stratified according to prior nitrosourea-based chemotherapy yes vs no Patients receive carboplatin IV over 30 minutes on day 1 and oral temozolomide once daily on days 1-5 Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity Patients with a persistent response may continue to receive temozolomide only for an additional 6 courses Cohorts of 3-6 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 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are accrued to receive carboplatin and temozolomide at the recommended phase II dose
PROJECTED ACCRUAL A total of 13-70 patients 3-30 for phase I and 10-40 for phase II 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 |
|---|---|---|---|
| NCI-V01-1650 | None | None | None |
| NYU-9948 | None | None | None |
| SPRI-NYU-9948 | None | None | None |
| NCI-G00-1907 | None | None | None |