Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045721
Status:
TERMINATED
Last Update Posted:
2009-10-16
First Post:
2002-09-06
Brief Title:
Carmustine Implants and O6-Benzylguanine in Treating Children With Recurrent Malignant Glioma
Sponsor:
Pediatric Brain Tumor Consortium
Organization:
Pediatric Brain Tumor Consortium
Study Overview
Official Title:
Phase I Trial of GLIADEL and O6-Benzylguanine in Pediatric Patients With Recurrent Malignant Gliomas
Status:
TERMINATED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor accrual
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 Chemotherapy placed into the surrounding tissue after surgery to remove the tumor may kill any remaining tumor cells O6-benzylguanine may increase the effectiveness of carmustine by making tumor cells more sensitive to the drug
PURPOSE Phase I trial to study the safety of combining O6-benzylguanine with carmustine implants in treating children who have recurrent malignant glioma
PURPOSE Phase I trial to study the safety of combining O6-benzylguanine with carmustine implants in treating children who have recurrent malignant glioma
Detailed Description:
OBJECTIVES
Determine the dose of O6-benzylguanine that reliably inhibits alkylguanine-DNA alkyltransferase activity in pediatric patients with recurrent malignant glioma
Describe the toxic effects of O6-benzylguanine with carmustine implant Gliadel in these patients
Investigate antitumor response in patients treated with this regimen
Characterize the pharmacokinetics of O6-benzylguanine when administered continuously over a 9-day period
OUTLINE This is a multicenter dose-escalation study of O6-benzylguanine
Patients receive O6-benzylguanine O6-BG IV over 1 hour immediately followed by O6-BG IV continuously for 9 days Two days after initiation of continuous infusion of O6-BG patients undergo maximal tumor debulking At the time of surgery patients receive up to 8 polifeprosan 20 wafers with carmustine Gliadel implanted into the resection cavity
Cohorts of up to 14 patients receive escalating doses of continuous infusion O6-BG until the optimally biologically effective dose BED is determined The BED is defined as the dose at which at least 11 of 14 patients meet the target of complete suppression of alkylguanine-DNA alkyltransferase levels
Patients are followed at day 11 at weeks 2 4 6 8 and 12 at months 6 9 and 12 every 6 months for 4 years and then annually for 5 years
PROJECTED ACCRUAL Approximately 20 patients will be accrued for this study within 2 years
Determine the dose of O6-benzylguanine that reliably inhibits alkylguanine-DNA alkyltransferase activity in pediatric patients with recurrent malignant glioma
Describe the toxic effects of O6-benzylguanine with carmustine implant Gliadel in these patients
Investigate antitumor response in patients treated with this regimen
Characterize the pharmacokinetics of O6-benzylguanine when administered continuously over a 9-day period
OUTLINE This is a multicenter dose-escalation study of O6-benzylguanine
Patients receive O6-benzylguanine O6-BG IV over 1 hour immediately followed by O6-BG IV continuously for 9 days Two days after initiation of continuous infusion of O6-BG patients undergo maximal tumor debulking At the time of surgery patients receive up to 8 polifeprosan 20 wafers with carmustine Gliadel implanted into the resection cavity
Cohorts of up to 14 patients receive escalating doses of continuous infusion O6-BG until the optimally biologically effective dose BED is determined The BED is defined as the dose at which at least 11 of 14 patients meet the target of complete suppression of alkylguanine-DNA alkyltransferase levels
Patients are followed at day 11 at weeks 2 4 6 8 and 12 at months 6 9 and 12 every 6 months for 4 years and then annually for 5 years
PROJECTED ACCRUAL Approximately 20 patients will be accrued for this study within 2 years
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 |
|---|---|---|---|
| PBTC-009 | None | None | None |