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



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

For Condition: unspecified adult solid tumor, protocol specific
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , University of Chicago Cancer Research Center
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: 
Protocol Entry Criteria: PROTOCOL 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
MarkRatain,  Study Chair,  University of Chicago Cancer Research Center

University of Chicago Cancer Research Center
Chicago,  Illinois,  60637-1470
United States
 


Additional Information:
Study ID Numbers:
  CDR0000066892;  UCCRC-9523,NCI-T98-0038
Study Start Date: October 1999
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003766

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4. Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer

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