Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm
Brain and Central Nervous System Tumors, Metastatic Cancer
About this trial
This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult glioblastoma, tumors metastatic to brain, adult anaplastic astrocytoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed recurrent supratentorial malignant glioma with clear evidence of progression by MRI Glioblastoma multiforme Anaplastic ependymoma Anaplastic astrocytoma Anaplastic oligodendroglioma OR Metastatic tumor to the brain other than melanoma Planned resection of tumor (must be first surgery for recurrent disease) Tumor volume of each tumor component or residual tumor must be at least 4 cm3 and no greater than 33.4 cm3 Tumor shape and surrounding structure(s) unlikely to cause an irregular distribution of the injected study drug Tumor is spherical, spheroid, or ovoid No tumors shaped into 3 or more components (e.g., multicentric or multilobulated) No tumors extending into the ventricular system Tumor has an intact stroma (i.e., tumor mass not partially incised or punctured) Central necrosis and/or central cystic areas allowed if an enhancing rim with a thickness of more than 5 mm is present No tumors in the following locations of the brain: Brainstem (pons or medulla) Midbrain (mesencephalon) Primary sensorimotor cortex in the dominant hemisphere Within 1.5 cm of the optic chiasm, either optic nerve, or any other cranial nerve PATIENT CHARACTERISTICS: Age: 18 to 75 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 No evidence of bleeding diathesis Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT and SGPT no greater than 2.5 times normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 40 mL/min OR BUN no greater than 30 mg/dL Other: No active uncontrolled infection Afebrile (37.5 degrees C) unless fever due to tumor No other unstable or severe medical condition No complicating medical or psychiatric problem that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas, mitomycin, or Gliadel wafers) and recovered No anti-tumor chemotherapy within 12 weeks after study drug unless tumor volume increases by more than 25% by MRI Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No prior intracranial brachytherapy No anti-tumor radiotherapy within 12 weeks after study drug unless tumor volume increases by more than 25% by MRI Surgery: See Disease Characteristics Prior surgery allowed No anti-tumor surgery within 12 weeks after study drug Other: No concurrent anticoagulants No other concurrent investigational agents
Sites / Locations
- UCSF Cancer Center and Cancer Research Institute
- Massey Cancer Center