Tetra-O-Methyl Nordihydroguaiaretic Acid in Treating Patients With Recurrent High-Grade Glioma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed malignant glioma, including any of the following subtypes:
• •* Anaplastic astrocytoma
• •* Anaplastic oligodendroglioma
• •* Glioblastoma multiforme
• •Progressive or recurrent disease after radiation therapy with or without chemotherapy
• •* Patients with a previous low-grade glioma that has progressed to biopsy-confirmed high-grade glioma after radiation therapy with or without chemotherapy are eligible
• •Contrast-enhancing measurable disease by MRI or CT scan
• •PATIENT CHARACTERISTICS:
• •Karnofsky performance status 60-100%
• •Absolute neutrophil count ≥ 1,500/mm³
• •Hemoglobin ≥ 9 g/dL
• •Platelet count ≥ 100,000/mm³
• •Creatinine ≤ 1.5 mg/dL
• •Bilirubin ≤ 1.5 mg/dL
• •Transaminases ≤ 4 times upper limit of normal
• •Prothrombin Time (PT)/partial thromboplastin time (PTT) /international normalized ratio (INR) normal
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective barrier contraception during and for 2 months after completion of study treatment
• •Mini Mental State Exam score ≥ 15
• •No serious concurrent infection or medical illness that would impair the ability to safely receive study treatment
• •No other prior or concurrent malignancy within the past 5 years except for curatively treated carcinoma in situ or basal cell carcinoma of the skin
• •No known sensitivity to any of the study medication components (i.e., polyethylene glycol \[PEG 300\] and 2-hydroxypropyl β-cyclodextrin)
• •PRIOR CONCURRENT THERAPY:
• •See Disease Characteristics
• •Recovered from prior therapy
• •At least 3 months since prior radiation therapy
• •At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
• •At least 2 weeks since prior Federal Drug Administration (FDA)-approved noncytotoxic therapy (e.g., celecoxib or thalidomide)
• •At least 3 weeks since prior investigational noncytotoxic agents
• •At least 10 days since prior anticonvulsant drugs that induce hepatic metabolic enzymes, including any of the following:
• •* Phenytoin
• •* Carbamazepine
• •* Phenobarbital
• •* Primidone
• •* Oxcarbazepine
• •* Ethosuximide
• •No other concurrent therapy for this tumor, including systemic chemotherapy or radiation therapy
• •* Concurrent steroids allowed