An Open-Label Dose-Ranging Study of the Safety of Taurolidine 2% Solution Administered Intravenously to Patients With Recurrent or Progressive High Grade Glioma

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed glioblastoma multiforme, anaplastic
astrocytoma, or gliosarcoma Recurrent or progressive disease after prior cytoreductive
surgery, radiotherapy, and adjuvant chemotherapy Ineligible for any additional
conventional therapeutic intervention

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Karnofsky 60-100% Life
expectancy: More than 12 weeks Hematopoietic: Absolute neutrophil count greater than
1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL
AST/ALT less than 3 times upper limit of normal No indication of acute hepatitis or
parenchymal liver disease No significant hepatic disease that would preclude study Renal:
Creatinine less than 1.7 mg/dL No significant renal disease that would preclude study
Cardiovascular: No significant cardiac disease that would preclude study Other: HIV
negative No other active malignancy except curatively treated carcinoma in situ of the
cervix or basal cell skin cancer No significant psychiatric disease that would preclude
study No significant gastrointestinal disease that would preclude study No known
hypersensitivity to taurolidine or its excipients Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior interferon
Chemotherapy: See Disease Characteristics At least 2 weeks since prior vincristine At
least 3 weeks since prior temozolomide or procarbazine At least 4 weeks since prior
nitrosoureas Concurrent polifeprosan 20 with carmustine implant (Gliadel wafers) allowed
Endocrine therapy: At least 2 weeks since prior tamoxifen Concurrent corticosteroids
allowed Radiotherapy: See Disease Characteristics At least 2 weeks since prior
stereotactic radiosurgery Surgery: See Disease Characteristics Other: Recovered from prior
therapy At least 30 days since prior investigational drug At least 2 weeks since other
prior noncytotoxic agents No other concurrent experimental agent or protocol