O(6)-Benzylguanine in Treating Patients With Malignant Glioma

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: North American Brain Tumor Consortium; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: O(6)-benzylguanine

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 resection are eligible

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 us effective contraception

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