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

Study start date: October 1, 2003

Inclusion criteria: The patients must fulfill all the following criteria: * Previous histologically-confirmed diagnosis of primary GBM (glioma grade 4 at time of first diagnosis). * Histologically-confirmed and MRI diagnosed recurrent or progressive GBM after previous resection (surgical or biopsy) and radiation therapy. * Medically capable of undergoing the planned surgical gross total resection and the catheter placement. * Age ≥ 18. * Karnofsky Performance Status of ≥ 70%. * Life expectancy of ≥ 3 months. * Patients must already be taking or begin taking corticosteroids at a stable dose of 4 mg every 6 hours for at least 72 hours prior to catheter placement. * Patients must be capable of taking, or already taking, anticonvulsant medication. * Patients must have read, signed, and dated an informed consent according to ICH-GCP, the local regulatory requirement and the rules followed at each institution. 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).