A Randomized, Dose-Ranging, Safety and Tolerability Study of NBI-3001 Administered by Continuous Intratumoral Infusion Followed by Surgical Resection in Patients With Recurrent Glioblastoma Multiforme

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed recurrent or progressive glioblastoma
multiforme Previously treated with cytoreductive surgery Unilateral, unifocal tumor with a
volume of 5-80 mL Not eligible for further radiotherapy due to prior external beam
radiotherapy No multifocal, brain stem, or infratentorial tumor or tumor invading midline
No tumor with a clinically significant mass effect (greater than 5 mm midline shift) while
on stable dose of corticosteroid No clinical symptoms attributed to uncontrolled increased
intracranial pressure and/or edema of the brain

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not
specified Other: No focal or generalized seizure(s) within 30 days prior to enrollment No
other prior or concurrent malignancy except carcinoma in situ of the cervix or basal cell
or squamous cell skin cancer No medical instability due to non-malignant systemic disease
No other prior or concurrent condition that would preclude study compliance Not pregnant
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since prior antineoplastic chemotherapy Endocrine therapy: See Disease Characteristics
Stable dose of dexamethasone for at least 72 hours prior to catheter placement
Radiotherapy: See Disease Characteristics No prior radiosurgery boost (e.g., gamma knife
or stereotactic radiosurgery) At least 8 weeks since prior radiotherapy Surgery: See
Disease Characteristics At least 4 weeks since prior craniotomy