Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003765
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
1999-11-01
Brief Title:
O6-benzylguanine and Carmustine in Treating Children With Refractory CNS Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Trial of 06-BG and BCNU in Children With CNS Tumors
Status:
COMPLETED
Status Verified Date:
2007-10
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:
Phase I trial to study the effectiveness of O6-benzylguanine and carmustine in treating children who have refractory CNS tumors 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
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose and the dose limiting toxicity of carmustine administered after O6-benzylguanine in children with refractory primary CNS tumors
II Determine a safe and tolerable dose of carmustine administered after O6-benzylguanine to be used in phase II studies
III Determine the pharmacokinetics of O6-benzylguanine and its metabolite O6-benzyl-8-oxoguanine in these patients
IV Seek preliminary evidence of antitumor activity of this regimen in these patients
V Evaluate the acute and chronic toxicities and describe cumulative toxicity in patients treated with multiple courses of this regimen
OUTLINE This is a dose escalation study of carmustine
Patients receive O6-benzylguanine IV over 1 hour then 1 hour later carmustine IV is administered over 1 hour Treatment is repeated every 6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients each receive escalating doses of carmustine until the maximum tolerated dose MTD is reached The MTD is defined as the dose level at which fewer than 2 of 6 patients experience dose limiting toxicity DLT If myelosuppression is the DLT stratum 1 is closed and patients are accrued to stratum 2 If neutropenia is the DLT in stratum 2 patients receive filgrastim G-CSF subcutaneously beginning on day 2 and continuing until blood counts recover Patients are followed every 6 months for 4 years then annually thereafter
I Determine the maximum tolerated dose and the dose limiting toxicity of carmustine administered after O6-benzylguanine in children with refractory primary CNS tumors
II Determine a safe and tolerable dose of carmustine administered after O6-benzylguanine to be used in phase II studies
III Determine the pharmacokinetics of O6-benzylguanine and its metabolite O6-benzyl-8-oxoguanine in these patients
IV Seek preliminary evidence of antitumor activity of this regimen in these patients
V Evaluate the acute and chronic toxicities and describe cumulative toxicity in patients treated with multiple courses of this regimen
OUTLINE This is a dose escalation study of carmustine
Patients receive O6-benzylguanine IV over 1 hour then 1 hour later carmustine IV is administered over 1 hour Treatment is repeated every 6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients each receive escalating doses of carmustine until the maximum tolerated dose MTD is reached The MTD is defined as the dose level at which fewer than 2 of 6 patients experience dose limiting toxicity DLT If myelosuppression is the DLT stratum 1 is closed and patients are accrued to stratum 2 If neutropenia is the DLT in stratum 2 patients receive filgrastim G-CSF subcutaneously beginning on day 2 and continuing until blood counts recover Patients are followed every 6 months for 4 years then annually thereafter
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 |
|---|---|---|---|
| CDR0000066891 | REGISTRY | PDQ Physician Data Query | None |
| POG-9870 | None | None | None |