Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002971
Status:
COMPLETED
Last Update Posted:
2018-06-27
First Post:
1999-11-01
Brief Title:
O6-Benzylguanine in Treating Patients With Malignant Glioma
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
A Phase I Trial of Pre-Surgical O6-Benzylguanine in the Treatment of Patients With Malignant Glioma
Status:
COMPLETED
Status Verified Date:
2018-06
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
PURPOSE Phase I trial to study the effectiveness of O6-benzylguanine given before surgery to patients who have malignant glioma
PURPOSE Phase I trial to study the effectiveness of O6-benzylguanine given before surgery to patients who have malignant glioma
Detailed Description:
OBJECTIVES
Determine the dose of O6-benzylguanine O6-BG that produces total depletion of tumor O6-alkylguanine-DNA alkyltransferase AGT levels in more than 90 of patients with cerebral anaplastic astrocytoma or glioblastoma multiforme
Determine the qualitative and quantitative toxicities of O6-BG in this patient population
OUTLINE This is a dose escalation study
Part I The first cohort of 10 patients receives O6-benzylguanine O6-BG IV over 1 hour at dose level 1 beginning 6 hours prior to surgery If at least 3 of 10 patients in the first cohort have detectable levels of O6-alkylguanine-DNA alkyltransferase AGT then a second cohort of 10 patients receives O6-BG as above at dose level 2 Dose escalation continues until at least 8 of 10 patients have undetectable AGT activity At this point 4 additional patients are accrued If at least 11 of 14 patients at this dose level have undetectable levels of AGT then this dose level constitutes the biologic modulatory dose of O6-BG If less than 11 of 14 patients have undetectable levels of AGT then 10 additional patients are treated at a higher dose If at any time 3 or more patients at a dose level have detectable AGT activity accrual is stopped at that dose level and patients are treated at the next higher dose level Part I closed to accrual effective 7102000
Part II An additional cohort of 14 patients receives O6-BG at dose level 5 beginning 18 hours prior to surgery
PROJECTED ACCRUAL Part I of this study closed to accrual effective 7102000 A total of 14 patients will be accrued for part II of this study at a rate of 3 patients per month
Determine the dose of O6-benzylguanine O6-BG that produces total depletion of tumor O6-alkylguanine-DNA alkyltransferase AGT levels in more than 90 of patients with cerebral anaplastic astrocytoma or glioblastoma multiforme
Determine the qualitative and quantitative toxicities of O6-BG in this patient population
OUTLINE This is a dose escalation study
Part I The first cohort of 10 patients receives O6-benzylguanine O6-BG IV over 1 hour at dose level 1 beginning 6 hours prior to surgery If at least 3 of 10 patients in the first cohort have detectable levels of O6-alkylguanine-DNA alkyltransferase AGT then a second cohort of 10 patients receives O6-BG as above at dose level 2 Dose escalation continues until at least 8 of 10 patients have undetectable AGT activity At this point 4 additional patients are accrued If at least 11 of 14 patients at this dose level have undetectable levels of AGT then this dose level constitutes the biologic modulatory dose of O6-BG If less than 11 of 14 patients have undetectable levels of AGT then 10 additional patients are treated at a higher dose If at any time 3 or more patients at a dose level have detectable AGT activity accrual is stopped at that dose level and patients are treated at the next higher dose level Part I closed to accrual effective 7102000
Part II An additional cohort of 14 patients receives O6-BG at dose level 5 beginning 18 hours prior to surgery
PROJECTED ACCRUAL Part I of this study closed to accrual effective 7102000 A total of 14 patients will be accrued for part II of this study at a rate of 3 patients per month
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| NCI-T96-0103 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000065479 | REGISTRY | None | None |