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


Phase 1
N/A
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine minimal dose

Outcome 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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Mark J. Ratain, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

9523

NCT ID:

NCT00003766

Start Date:

October 1999

Completion Date:

November 2001

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637