Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010036
Status:
COMPLETED
Last Update Posted:
2011-03-28
First Post:
2001-02-02
Brief Title:
Carboplatin Plus Irinotecan in Treating Patients With Glioblastoma Multiforme
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
A Phase III Trial of CPT-11 With Carboplatin in Patients With Glioblastoma Multiforme Prior to Radiation Therapy
Status:
COMPLETED
Status Verified Date:
2011-03
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 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 II trial to study the effectiveness of combining carboplatin with irinotecan in treating patients who have glioblastoma multiforme
PURPOSE Phase II trial to study the effectiveness of combining carboplatin with irinotecan in treating patients who have glioblastoma multiforme
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose MTD of carboplatin and irinotecan in patients with glioblastoma multiforme Phase I closed to accrual as of 62402
Determine the toxic effects of this regimen in these patients
Determine the objective response in patients treated with the established MTD of this regimen
Determine time to tumor progression and survival of patients treated with this regimen
OUTLINE This is a dose-escalation study Patients in the phase II portion of the study are stratified according to age under 60 vs 60 and over ECOG performance status 0-1 vs 2 and extent of resection total vs subtotal Phase I closed to accrual as of 62402
Within 4 weeks of surgery patients receive carboplatin IV over 30 minutes followed by irinotecan IV over 90 minutes on day 1 Treatment repeats every 4 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of carboplatin and irinotecan 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 irinotecan at the recommended phase II dose Phase I closed to accrual as of 62402
After chemotherapy all patients undergo radiotherapy
Patients are followed for 30 days
PROJECTED ACCRUAL A total of 24-107 patients 3-54 for phase I and 21-53 for phase II will be accrued for this study Phase I closed to accrual as of 62402
Determine the maximum tolerated dose MTD of carboplatin and irinotecan in patients with glioblastoma multiforme Phase I closed to accrual as of 62402
Determine the toxic effects of this regimen in these patients
Determine the objective response in patients treated with the established MTD of this regimen
Determine time to tumor progression and survival of patients treated with this regimen
OUTLINE This is a dose-escalation study Patients in the phase II portion of the study are stratified according to age under 60 vs 60 and over ECOG performance status 0-1 vs 2 and extent of resection total vs subtotal Phase I closed to accrual as of 62402
Within 4 weeks of surgery patients receive carboplatin IV over 30 minutes followed by irinotecan IV over 90 minutes on day 1 Treatment repeats every 4 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of carboplatin and irinotecan 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 irinotecan at the recommended phase II dose Phase I closed to accrual as of 62402
After chemotherapy all patients undergo radiotherapy
Patients are followed for 30 days
PROJECTED ACCRUAL A total of 24-107 patients 3-54 for phase I and 21-53 for phase II will be accrued for this study Phase I closed to accrual as of 62402
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 |
|---|---|---|---|
| P30CA016087 | NIH | None | None |
| NYU-9902 | None | None | None |
| P-UPJOHN-986475197 | None | None | None |
| NCI-G00-1909 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016087 |