A Multi-Center, Open-Label Clinical Study to Evaluate the Safety and Performance of the Proxima GliaSite RTS, a Radiation Delivery System, in Patients With Recurrent Malignant Brain Tumors Undergoing Surgical Resection

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed malignant glioma: Anaplastic astrocytoma
Anaplastic oligodendroglioma Glioblastoma multiforme Unifocal disease Progressive or
recurrent disease following radiation therapy and/or chemotherapy Must be eligible for
surgical resection of the tumor mass No unresectable leptomeningeal spread or ventricular
invasion outside the radiation treatment volume No exophytic ventricular tumors Must have
a maximal cross-sectional diameter enhancing tumor greater than 2.0 cm but not greater
than 5.0 cm by preoperative MRI Ratio of major axes of the tumor should not exceed 1.5 No
marked edema by preoperative MRI or CT that cannot be corrected by tumor resection

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: Greater than 3 months Hematopoietic: Not specified Hepatic: Not specified
Renal: Not specified Cardiovascular: No uncontrolled hypertension, angina pectoris, or
uncontrolled cardiac dysrhythmia Other: Not pregnant or nursing Fertile patients must use
effective contraception No serious concurrent infection or other medical illness No prior
or concurrent malignancy within 5 years except for curatively treated carcinoma in situ of
the cervix or basal cell carcinoma of the skin

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy:
See Disease Characteristics No concurrent chemotherapy At least 4 weeks since prior
chemotherapy (6 weeks since nitrosoureas) and recovered Endocrine therapy: Not specified
Radiotherapy: See Disease Characteristics At least 3 months since prior radiotherapy and
recovered Surgery: See Disease Characteristics Other: At least 4 weeks since prior use of
medical device No concurrent investigational agents