Phase I Brachytherapy Dose Escalating Study Using the Proxima Therapeutics, Inc. GliaSite RTS in Patients With Recurrent Malignant Gliomas

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed malignant glioma

- Anaplastic astrocytoma, anaplastic oligodendroglioma, or glioblastoma multiforme

- Low-grade astrocytoma that progresses to high-grade astrocytoma allowed

- Unifocal disease

- Progressive or recurrent after radiotherapy with or without chemotherapy

- Previously treated with at least 5,000 cGy external beam radiotherapy more
than 3 months ago

- Candidate for maximal surgical resection

- Any expected residual enhancing tumor must be within expected brachytherapy
treatment volume

- Resection must not be expected to result in a new permanent neurologic deficit

- No tumor crossing more than 1 cm beyond the midline on preoperative MRI or CT scan

- No grossly or radiographically apparent leptomeningeal spread

- No ventricular invasion outside the anticipated radiotherapy treatment volume

- No marked edema on MRI or CT scan

- Patients with 2 or more separate foci of contrast-enhancing tumors that are more than
5 cm apart on preoperative MRI or CT scan are ineligible

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Karnofsky 60-100%

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Not specified

Renal

- Creatinine no greater than 1.7 mg/dL

- BUN no greater than 2 times upper limit of normal

Cardiovascular

- No uncontrolled hypertension

- No unstable angina pectoris

- No uncontrolled cardiac dysrhythmia

Other

- Mini mental score at least 15

- No other medical illness that would preclude study participation

- No serious infection

- No other malignancy within the past 5 years except curatively treated carcinoma in
situ of the cervix or nonmelanoma skin cancer

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent immunotherapy

- No concurrent biologic agents (e.g., immunotoxins, immunoconjugates, antiangiogenesis
compounds, antisense therapy, peptide receptor antagonists, interferons,
interleukins, tumor-infiltrating lymphocytes, lymphokine-activated killer cells, or
gene therapy)

Chemotherapy

- See Disease Characteristics

- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)

- No concurrent polifeprosan 20 with carmustine implant (Gliadel wafer)

Endocrine therapy

- Concurrent corticosteroids allowed to improve quality of life

Radiotherapy

- See Disease Characteristics

- No concurrent radiosurgery

Surgery

- See Disease Characteristics

- See Radiotherapy

Other

- Recovered from prior therapy

- No prior investigational agents

- No investigational agents during and for 90 days after study participation

- Concurrent cytotoxic treatment allowed to improve quality of life