Chicago, Illinois 60637

  • Unspecified Adult Solid Tumor, Protocol Specific

Purpose:

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.


Study summary:

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. 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. PROJECTED ACCRUAL: A total of 13-26 patients will be accrued for this study over approximately 10 months.


Criteria:

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed surgically resectable solid tumor 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 PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified


Study is Available At:


Original ID:

9523


NCT ID:

NCT00003766


Secondary ID:

UCCRC-9523


Study Acronym:


Brief Title:

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


Official Title:

Determination of Optimal O6-Benzylguanine Dose to Achieve O6-Alkylguanine-DNA Alkyltransferase Depletion in Patients With Surgically Resectable Solid Tumors


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Chicago


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Pharmacodynamics Study, I


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

25


Enrollment Type:

Actual


Overall Contact Information

Official Name:Mark J. Ratain, MD
Study Chair
University of Chicago

Study Dates

Start Date:October 1999
Completion Date:November 2001
Completion Type:Actual
Primary Completion Date:November 2001
Primary Completion Type:Actual
Verification Date:March 2014
Last Changed Date:March 5, 2014
First Received Date:November 1, 1999

Study Outcomes

Outcome Type:Primary Outcome
Measure:Determine minimal dose
Time Frame:2 years
Safety Issues:False
Description:Determine minimal dose of 06-benzylguanine (06-BG) at which there is a depletion of tumor 06-BG DNA alkyltransferase activity to <10 fmol/mg protein

Study Interventions

Intervention Type:Drug
Name:O6-benzylguanine
Arm Name:Arm A

Study Arms

Study Arm Type:Experimental
Arm Name:Arm A
Description:06-benzylguanine (100mg/m2 16 hrs before anticipated tumor tissue removal)

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Chicago
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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