Safety and Efficacy Study to Treat Recurrent Grade 4 Malignant Brain Tumors

Exclusion Criteria

• •Patients fulfilling any of the following criteria should not be enrolled in the study:
• •Previous myelosuppressive chemotherapy within the past 4 weeks of the start of the infusion. Patients who have received more than two chemotherapy regimens (single therapy or combination therapy) are ineligible.
• •Any form of brain radiation within 10 weeks of the start of the infusion.
• •Previous gamma knife radiosurgery, stereotactic radiosurgery, and/or internal radiotherapy, unless the recurrence/progression is histologically confirmed (fine-needle biopsy).
• •Prior intracavitary biologic response modifiers or monoclonal antibodies.
• •Uncontrolled seizures.
• •Bilateral or multifocal tumors.
• •Evidence of cerebral uncal herniation.
• •Midline brain shift on MRI scan of \> 0.5 cm prior to resection; patients with subfalcine herniation may be enrolled.
• •Tumors involving the brainstem or cerebellum.
• •Diffuse subependymal or CSF disease.
• •Women who are pregnant or breast feeding. All women of child-bearing potential should be excluded unless they have a negative pregnancy test and are using adequate contraceptive measures or are surgically sterile. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing.
• •Fertile males not practicing adequate contraception and whose female partners are not using adequate contraceptive protection.
• •Prior or concurrent investigational treatment within 30 days of study entry.
• •Active infection requiring treatment or having an unexplained febrile illness.
• •Systemic diseases or other conditions which may be associated with unacceptable anesthetic/operative risk and/or which would not allow safe completion of this study protocol.
• •Prior or concurrent malignancy (curatively treated carcinoma-in-situ or basal cell carcinoma or patients who have been disease free for at least 5 years are eligible).