A Phase I/II Trial of BMS-247550 for Treatment of Patients With Recurrent High-Grade Gliomas

Inclusion Criteria

• •Patients must have histologically proven malignant glioma (anaplastic astrocytoma or glioblastoma multiforme) which is progressive or recurrent following radiation therapy +/- chemotherapy; patients with previous low grade glioma who progressed after radiotherapy +/- chemotherapy and are biopsied and found to have a high grade glioma are eligible
• •Patients must have measurable progressive or recurrent malignant glioma by MRI or CT imaging
• •Patients must have recovered from severe toxicity of prior therapy; an interval of at least 3 months must have elapsed since the completion of the most recent course of radiation therapy while at least 3 weeks must have elapsed since the completion of a non-nitrosourea containing chemotherapy regimen and at least 6 weeks since the completion of a nitrosourea containing chemotherapy regimen
• •Patients must have a Karnofsky performance status \>= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
• •Absolute neutrophil count \>= 1500/mm\^3
• •Platelets \>= 100,000/mm\^3
• •HgB \> 9 g/dl
• •Creatinine =\< 1.5mg/dl
• •Total Bilirubin =\< 1.5mg/dl
• •Transaminases =\< 2.5 times above the upper limits of the institutional norm)
• •Patients must be able to provide written informed consent
• •Patients must have =\< 2 prior chemotherapy regimens
• •Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; the anti-proliferative activity of this experimental drug may be harmful to the developing fetus or nursing infant; female patients of child-bearing potential must have a negative pregnancy test
• •Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast; patients with prior malignancies must be disease-free for \>= five years
• •Patients must be maintained on a stable corticosteroid regimen from the time of their baseline scan until the start of treatment
• •Patients must have a Mini Mental State Exam score of \>= 15