Clinical Trial Finder

INCLUSION CRITERIA:

DISEASE CHARACTERISTICS-

• - Histologically confirmed recurrent glioblastoma multiforme (including gliosarcoma) which can be confirmed, if not earlier, by intraoperative pathological diagnosis on frozen section.

• - Evidence of a unilateral, single focus of measurable Central Nervous System (CNS) neoplasm on contrast-enhanced magnetic resonance imaging (MRI) or computed tomography (CT) scan that is supratentorial and measures ≥ 1.0 cm in diameter.

PATIENT CHARACTERISTICS-

• - Greater than or equal to 18 years old.

• - Life expectancy of greater than 12 weeks.

• - Karnofsky performance status greater than or equal to 60% - Absolute neutrophil count ≥ 1,000/millimeters (mm)³ - Platelet count ≥ 100,000/mm³ - Total Serum Bilirubin < 2 times upper limit of normal (ULN) - Serum glutamic oxaloacetic transaminase (SGOT) < 3 times ULN.

• - Blood urea nitrogen (BUN) < 1.5 times ULN.

• - Creatinine < 1.5 times ULN.

• - Negative pregnancy test.

• - Recovered from any effects of major surgery.

• - Patients or legal guardian must give written, informed consent.

PRIOR CONCURRENT THERAPY-

• - At least 2 weeks since prior surgical resection (if conducted) and recovered, unless there is unequivocal evidence of tumor progression.

• - At least 4 weeks since prior radiotherapy or chemotherapy (6 weeks for nitrosoureas), unless there is unequivocal evidence of tumor progression.

. However, patients treated with chemotherapeutic agents such as etoposide who would normally be retreated after shorter intervals (eg, 21 days on, 7 days off schedule) may be treated at the usual starting time even if less than 4 weeks from the last prior dose of chemotherapy.

EXCLUSION CRITERIA:

• - Patients who have not recovered from surgery.

• - Patients who are not neurologically stable for 2 weeks prior to study entry.

• - Patients who are poor medical risks because of non-malignant systemic disease as well as those with acute infection treated with intravenous antibiotics.

• - Frequent vomiting or medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction) - Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention.

• - Known HIV positivity or AIDS-related illness.

• - Pregnant or nursing women.

• - Women of childbearing potential who are not using an effective method of contraception.

Women of childbearing potential must have a negative serum pregnancy test 24 hours prior to administration of study drug and be practicing medically approved contraceptive precautions.

• - Men who are not advised to use an effective method of contraception.

• - Patients taking immuno-suppressive agents other than prescribed corticosteroids.

• - Patients who have had prior treatment with Gliadel Wafers.

OBJECTIVES:

• - Define the activity of Gliadel® wafers in combination with a 5-day infusion of O6-benzylguanine in patients with recurrent glioblastoma multiforme.

• - Define the toxicity of Gliadel® wafers in combination with 5-day infusion of O6-benzylguanine in patients with recurrent glioblastoma multiforme.

OUTLINE: This is an open-label study. Patients undergo surgical resection of tumor followed by placement of Gliadel® wafers . Within 6 hours after completion of surgery, patients receive a 1 hour high dose infusion of O6-benzylguanine followed by a lower dose continuous infusion for 5 days. Every 48 hours a repeat infusion of the high dose over 1 hour will be administered for a total of 3 doses. After completion of study treatment, patients are followed every 8 weeks. PROJECTED ACCRUAL: A total of 50 patients should be accrued for this study.

Arms

Experimental: Gliadel wafers in combination with O6-benzylguanine

Interventions

Drug: - Gliadel wafers in combination with O6-benzylguanine