Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003766
Status:
COMPLETED
Last Update Posted:
2014-03-06
First Post:
1999-11-01
Brief Title:
O6-benzylguanine Followed by Surgery in Treating Patients With Solid Tumors That Can Be Removed During Surgery
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Determination of Optimal O6-Benzylguanine Dose to Achieve O6-Alkylguanine-DNA Alkyltransferase Depletion in Patients With Surgically Resectable Solid Tumors
Status:
COMPLETED
Status Verified Date:
2014-03
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 Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery
PURPOSE Phase II trial to study the effectiveness of O6-benzylguanine followed by surgery in treating patients who have solid tumors that can be removed during surgery
PURPOSE Phase II trial to study the effectiveness of O6-benzylguanine followed by surgery in treating patients who have solid tumors that can be removed during surgery
Detailed Description:
OBJECTIVES I Determine the minimal O6-benzylguanine O6-BG dose required to deplete tumor activity to less than 10 fmolmg protein at a specified time after administration in patients with surgically resectable solid tumors II Correlate tumor tissue AGT depletion with AGT depletion in peripheral blood mononuclear cells PBMC obtained at a specified time after O6-BG administration in these patients
OUTLINE This is a dose escalation study Patients receive a single dose of O6-benzylguanine O6-BG IV over 1 hour at one of two dose levels Patients undergo surgery 16-20 hours after administration of O6-BG Up to 13 patients receive the lower dose level of O6-BG If more than 3 patients have detectable AGT levels additional patients receive the higher dose The optimal biologic dose OBD is defined as the lowest dose level at which at least 11 of 13 patients have AGT activity less than 10 fmolmg protein after O6-BG dosing Patients are followed at 1 and 3 weeks post surgery
PROJECTED ACCRUAL A total of 13-26 patients will be accrued for this study over approximately 10 months
OUTLINE This is a dose escalation study Patients receive a single dose of O6-benzylguanine O6-BG IV over 1 hour at one of two dose levels Patients undergo surgery 16-20 hours after administration of O6-BG Up to 13 patients receive the lower dose level of O6-BG If more than 3 patients have detectable AGT levels additional patients receive the higher dose The optimal biologic dose OBD is defined as the lowest dose level at which at least 11 of 13 patients have AGT activity less than 10 fmolmg protein after O6-BG dosing Patients are followed at 1 and 3 weeks post surgery
PROJECTED ACCRUAL A total of 13-26 patients will be accrued for this study over approximately 10 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 |
|---|---|---|---|
| NCI-T98-0038 | None | None | None |
| UCCRC-9523 | None | None | None |