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.
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.
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed surgically resectable
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: