A Phase I Study of Concurrent Multi-modality Treatment for Patients With Relapsed Malignant Glioma Using Permanent I-125 Interstitial Seeds and Dose Escalation of Gliadel 3.85% Carmustine (BCNU) Polymer Wafers

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed recurrent or refractory glioblastoma
multiforme, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic
oligoastrocytoma (mixed glioma), anaplastic pleomorphic xanthoastrocytoma, or malignant
dedifferentiation from prior low grade glioma Tumor in first relapse Measurable disease by
MRI scan Enhancing lesion amenable to gross total resection Postoperative resection cavity
not communicating freely with ventricular system

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: Greater than 8 weeks Hematopoietic: Absolute neutrophil count greater than
1,000/mm3 Hemoglobin greater than 10.0 g/dL Platelet count greater than 100,000/mm3
Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT or SGPT less than
2.5 times ULN Renal: Not specified Other: Not pregnant or nursing Negative pregnancy test
Fertile patients must use effective contraception HIV negative No AIDS-related illness No
other malignancy within past 5 years, except: Basal or squamous cell carcinoma of the skin
Carcinoma in situ of the cervix No psychological, familial, sociological, or geographical
conditions that would interfere with study compliance No active infection requiring
systemic antibiotics No nonmalignant systemic disease considered to increase medical risk

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy:
At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin) and
recovered No prior polifeprosan 20 with carmustine implant (Gliadel wafers) Prior adjuvant
chemotherapy allowed No other concurrent chemotherapy Endocrine therapy: Patient on stable
steroid therapy for at least 2 weeks prior to study No concurrent hormonal agents
Radiotherapy: Prior radiosensitization allowed and recovered Prior external beam
radiotherapy required and recovered No concurrent radiotherapy (including palliative)
Surgery: Prior surgery or biopsy required and recovered Other: No prior iodine I 125 seed
implants Concurrent alternative therapy allowed No other concurrent antineoplastic therapy
No other concurrent investigational drugs