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Home > "O" Clinical Trials Conditions > O(6)-benzylguanine in Treating Patients With Malignant Glioma  O(6)-benzylguanine in Treating Patients With Malignant Glioma
O(6)-benzylguanine in Treating Patients With Malignant Glioma
For Condition: recurrent adult brain tumor,adult anaplastic astrocytoma,adult glioblastoma multiforme
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , North American Brain Tumor Consortium
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of O(6)-benzylguanine given before surgery to patients who have malignant glioma.
Details: OBJECTIVES: I. Determine the dose of O6-benzylguanine (O6-BG) that produces total depletion of tumor O6-alkylguanine-DNA alkyltransferase (AGT) levels in more than 90% of patients with cerebral anaplastic astrocytoma or glioblastoma multiforme. II. Determine the qualitative and quantitative toxicities of O6-BG in this patient population. PROTOCOL OUTLINE: This is a dose escalation study. Part I: The first cohort of 10 patients receives O6-benzylguanine (O6-BG) IV over 1 hour at dose level 1 beginning 6 hours prior to surgery. If at least 3 of 10 patients in the first cohort have detectable levels of O6-alkylguanine-DNA alkyltransferase (AGT), then a second cohort of 10 patients receives O6-BG as above at dose level 2. Dose escalation continues until at least 8 of 10 patients have undetectable AGT activity. At this point, 4 additional patients are accrued. If at least 11 of 14 patients at this dose level have undetectable levels of AGT, then this dose level constitutes the biologic modulatory dose of O6-BG. If less than 11 of 14 patients have undetectable levels of AGT, then 10 additional patients are treated at a higher dose. If at any time 3 or more patients at a dose level have detectable AGT activity, accrual is stopped at that dose level and patients are treated at the next higher dose level. (Part I closed to accrual effective 7/10/2000) Part II: An additional cohort of 14 patients receives O6-BG at dose level 5 beginning 18 hours prior to surgery. PROJECTED ACCRUAL: Part I of this study closed to accrual effective 7/10/2000. A total of 14 patients will be accrued for part II of this study at a rate of 3 patients per month.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Must be undergoing a diagnostic/therapeutic craniotomy for biopsy/resection of recurrent or newly diagnosed (or presumed) cerebral anaplastic astrocytoma or glioblastoma multiforme; Patients undergoing stereotactic biopsy or partial resectioning are eligible --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: Must have failed or received no prior treatment with a nitrosourea, procarbazine, or temozolomide; No prior O6-benzylguanine; At least 4 weeks since prior chemotherapy and recovered - Endocrine therapy: Not specified - Radiotherapy: At least 6 weeks since prior radiotherapy; No prior radiotherapy to greater than 10-20% of bone marrow - Other: No concurrent therapy for any other malignancy; At least 2 weeks since other prior investigational drug --Patient Characteristics-- - Age: 18 and over - Performance status: SWOG 0-2 OR Karnofsky 60-100% - Hematopoietic: WBC at least 3,500/mm3; Absolute neutrophil count at least 1,800/mm3; Platelet count at least 125,000/mm3; Hemoglobin at least 9 g/dL - Hepatic: Bilirubin less than 1.5 mg/dL; SGOT less than 2 times upper limit of normal - Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 70 mL/min - Cardiovascular: No cardiovascular illnesses that cannot be adequately controlled with appropriate therapy or would increase risk, e.g.: Severe cardiac disease such as uncontrolled arrhythmias or conduction defects; Major problems with edema (e.g., residual leg swelling from deep venous thrombosis); Recent coronary artery disease; Poorly controlled hypertension (systolic pressure greater than 180 mm Hg, diastolic pressure greater than 110 mm Hg) - Other: No other medical illnesses that cannot be adequately controlled with appropriate therapy or would increase risk, e.g.: Major problems with edema (e.g., Cushing's syndrome); Major psychiatric illness; No other malignancy requiring active therapy; Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelPrados, Study Chair, North American Brain Tumor Consortium
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Additional Information:
Study ID Numbers: CDR0000065479; NABTC-9702,NCI-T96-0103
Study Start Date: July 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002971
Other Recurrent Adult Brain Tumor Studies:
1. Bispecific Antibody Plus White Blood Cells in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme
2. Antineoplaston Therapy in Treating Patients With Glioblastoma Multiforme
3. Temozolomide in Treating Patients With Recurrent Malignant Glioma
4. SarCNU in Treating Patients With Recurrent Malignant Glioma
5. Photodynamic Therapy in Treating Patients With Recurrent Malignant Supratentorial Gliomas
Related Studies:
Other recurrent adult brain tumor Clinical Trials
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O(6)-benzylguanine in Treating Patients With Malignant Glioma
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