Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

O6-benzylguanine Followed by Surgery in Treating Patients With Solid Tumors That Can Be Removed During Surgery

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	Not specified	NCI	UCCRC-9523 NCI-T98-0038, NCT00003766, T98-0038

Objectives

I.  Determine the minimal O6-benzylguanine (O6-BG) dose required to deplete 
tumor activity to less than 10 fmol/mg 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.

Entry Criteria

Disease Characteristics:

Histologically or cytologically confirmed surgically resectable solid tumor

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 No prior chemotherapy

Endocrine therapy:
 Not specified

Radiotherapy:
 No prior radiotherapy

Surgery:
 Not specified

Patient Characteristics:

Age:
 Not specified

Performance status:
 CALGB 0-2

Life expectancy:
 Not specified

Hematopoietic:
 Not specified

Hepatic:
 Bilirubin no greater than 1.5 times upper limit of normal (ULN)

Renal:
 Creatinine no greater than 1.5 times ULN

Other:
 Not pregnant or nursing
 Medically cleared for surgery
 No active medical or psychiatric disease that would prevent compliance

Expected Enrollment

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 fmol/mg 
protein after O6-BG dosing. 

Patients are followed at 1 and 3 weeks post surgery.

Trial Contact Information

Trial Lead Organizations

University of Chicago Cancer Research Center

Mark Ratain, MD, Protocol chair		Ph: 773-702-4400; 888-824-0200

Registry Information
Official Title		Determination of Optimal O6-Benzylguanine Dose to Achieve O6-Alkylguanine-DNA Alkyltransferase Depletion in Patients with Surgically Resectable Solid Tumors
Trial Start Date		1999-10-28
Registered in ClinicalTrials.gov		NCT00003766
Date Submitted to PDQ		1999-01-29
Information Last Verified		2007-10-18
NCI Grant/Contract Number		CA14599, CA69852