Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003463
Status:
COMPLETED
Last Update Posted:
2013-02-18
First Post:
1999-11-01
Brief Title:
Carmustine Wafers Plus Irinotecan in Treating Patients With Recurrent Supratentorial High Grade Gliomas
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Phase I Treatment of Adults With Recurrent Supratentorial High Grade Glioma With Gliadel Wafers Plus Irinotecan CPT-11
Status:
COMPLETED
Status Verified Date:
2013-02
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 I trial to study the effectiveness of carmustine wafers plus irinotecan in treating patients with recurrent supratentorial high grade gliomas
PURPOSE Phase I trial to study the effectiveness of carmustine wafers plus irinotecan in treating patients with recurrent supratentorial high grade gliomas
Detailed Description:
OBJECTIVES
Define the maximum tolerated dose of irinotecan given in combination with Gliadel wafers carmustine in patients with recurrent glioblastoma multiforme anaplastic astrocytoma or gliosarcoma
Define the toxicity of irinotecan given in combination with Gliadel wafers in these patients
OUTLINE This is a dose escalation study
All patients undergo surgical resection At the time of surgery up to eight Gliadel wafers containing carmustine are implanted in the resected tumor cavity
Cohorts of 3 patients each receive escalating doses of irinotecan IV over 90 minutes once weekly within 3 weeks after Gliadel wafer implantation One course of treatment consists of 4 weeks of irinotecan and 2 weeks of rest If 1 patient experiences dose limiting toxicity DLT at a dose level an additional 3 patients are entered at that same dose level If 2 patients experience DLT the maximum tolerated dose MTD has been surpassed and a total of 6 patients are treated at the previous dose level The MTD is defined as the highest dose in which no more than 1 of 6 patients experiences DLT
Treatment continues for up to 12 courses in the absence of unacceptable toxicity and disease progression
Patients are followed for at least 4 months
PROJECTED ACCRUAL Approximately 18 patients will be accrued into this study over 9 months
Define the maximum tolerated dose of irinotecan given in combination with Gliadel wafers carmustine in patients with recurrent glioblastoma multiforme anaplastic astrocytoma or gliosarcoma
Define the toxicity of irinotecan given in combination with Gliadel wafers in these patients
OUTLINE This is a dose escalation study
All patients undergo surgical resection At the time of surgery up to eight Gliadel wafers containing carmustine are implanted in the resected tumor cavity
Cohorts of 3 patients each receive escalating doses of irinotecan IV over 90 minutes once weekly within 3 weeks after Gliadel wafer implantation One course of treatment consists of 4 weeks of irinotecan and 2 weeks of rest If 1 patient experiences dose limiting toxicity DLT at a dose level an additional 3 patients are entered at that same dose level If 2 patients experience DLT the maximum tolerated dose MTD has been surpassed and a total of 6 patients are treated at the previous dose level The MTD is defined as the highest dose in which no more than 1 of 6 patients experiences DLT
Treatment continues for up to 12 courses in the absence of unacceptable toxicity and disease progression
Patients are followed for at least 4 months
PROJECTED ACCRUAL Approximately 18 patients will be accrued into this study over 9 months
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 |
|---|---|---|---|
| CDR0000066497 | OTHER | NCI | None |
| DUMC-0901-02-5R4 | None | None | None |
| DUMC-0901-02-5R2 | None | None | None |
| DUMC-000901-00-5R2 | None | None | None |
| DUMC-000901-01-5R3 | None | None | None |
| DUMC-0797-99-5RI | None | None | None |
| DUMC-796-98-5 | None | None | None |
| DUMC-98065 | None | None | None |
| UCLA-9812060 | None | None | None |
| NCI-G98-1464 | None | None | None |
| DUMC-0901-01-5R3 | None | None | None |