Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006474
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2000-11-06
Brief Title:
Temozolomide and O6-benzylguanine in Treating Patients With Newly Diagnosed Recurrent or Progressive Anaplastic Glioma
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Phase I Trial of Temodar Plus O6-Benzylguanine O6-BG NSC 637037 in the Treatment of Patients With Newly Diagnosed Part 1 or RecurrentProgressive Parts 1 and 2 Cerebral Anaplastic Gliomas
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 combining temozolomide and O6-benzylguanine in treating patients who have newly diagnosed recurrent or progressive anaplastic glioma
PURPOSE Phase I trial to study the effectiveness of combining temozolomide and O6-benzylguanine in treating patients who have newly diagnosed recurrent or progressive anaplastic glioma
Detailed Description:
OBJECTIVES
Determine the dose of O6-benzylguanine O6-BG effective in producing complete suppression of tumor O6-alkylguanine-DNA alkyltransferase activity in patients with newly diagnosed closed to accrual 12192000 or recurrent or progressive cerebral anaplastic glioma
Determine the maximum tolerated dose of temozolomide administered after O6-BG in these patients
Determine the toxicity of this regimen in these patients
Determine the anti-tumor response in patients treated with this regimen
OUTLINE This is a dose-escalation multicenter study
Part I Patients receive escalating doses of O6-benzylguanine O6-BG IV continuously for 49 hours until the dose that produces the target depletion of tumor O6-alkylguanine-DNA alkyltransferase AGT is determined Patients undergo a craniotomy after completion of the O6-BG infusion closed to accrual 12192000
Part II After determination of the O6-BG dose in Part I patients with recurrent malignant gliomas receive O6-BG IV continuously for 49 hours beginning on day 1 Patients also receive oral temozolomide on day 1 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity
PROJECTED ACCRUAL Approximately 20-30 patients with 14 patients participating in Part II will be accrued for this study
Determine the dose of O6-benzylguanine O6-BG effective in producing complete suppression of tumor O6-alkylguanine-DNA alkyltransferase activity in patients with newly diagnosed closed to accrual 12192000 or recurrent or progressive cerebral anaplastic glioma
Determine the maximum tolerated dose of temozolomide administered after O6-BG in these patients
Determine the toxicity of this regimen in these patients
Determine the anti-tumor response in patients treated with this regimen
OUTLINE This is a dose-escalation multicenter study
Part I Patients receive escalating doses of O6-benzylguanine O6-BG IV continuously for 49 hours until the dose that produces the target depletion of tumor O6-alkylguanine-DNA alkyltransferase AGT is determined Patients undergo a craniotomy after completion of the O6-BG infusion closed to accrual 12192000
Part II After determination of the O6-BG dose in Part I patients with recurrent malignant gliomas receive O6-BG IV continuously for 49 hours beginning on day 1 Patients also receive oral temozolomide on day 1 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity
PROJECTED ACCRUAL Approximately 20-30 patients with 14 patients participating in Part 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 |
|---|---|---|---|
| DUMC-1388-02-8R2 | None | None | None |
| NCI-490 | None | None | None |
| DUMC-1388-00-8 | None | None | None |
| DUMC-1388-01-8R1 | None | None | None |
| CDR0000068301 | OTHER | DUMC | None |