O6-benzylguanine Followed by Surgery in Treating Patients With Solid Tumors That Can Be Removed During Surgery
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| First Received Date ICMJE | November 1, 1999 | ||||
| Last Updated Date | February 15, 2013 | ||||
| Start Date ICMJE | October 1999 | ||||
| Primary Completion Date | February 2001 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Determine minimal dose [ Time Frame: 2 years ] [ Designated as safety issue: No ] 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 |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00003766 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | O6-benzylguanine Followed by Surgery in Treating Patients With Solid Tumors That Can Be Removed During Surgery | ||||
| Official Title ICMJE | Determination of Optimal O6-Benzylguanine Dose to Achieve O6-Alkylguanine-DNA Alkyltransferase Depletion in Patients With Surgically Resectable Solid Tumors | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Unspecified Adult Solid Tumor, Protocol Specific | ||||
| Intervention ICMJE | Drug: O6-benzylguanine | ||||
| Study Arm (s) | Experimental: Arm A
06-benzylguanine (100mg/m2 16 hrs before anticipated tumor tissue removal)
Intervention: Drug: O6-benzylguanine |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 25 | ||||
| Completion Date | November 2001 | ||||
| Primary Completion Date | February 2001 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00003766 | ||||
| Other Study ID Numbers ICMJE | 9523, UCCRC-9523, NCI-T98-0038 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Mark Ratain, University of Chicago | ||||
| Study Sponsor ICMJE | University of Chicago | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Chicago | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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