safety and efficacy study to treat recurrent grade 4 malignant brain tumors

Conditions: Glioblastoma Multiforme

Summary: immunotoxin therapy may be effective in treating malignant glioma. immunotoxins can locate tumor cells and kill them without harming normal cells.


Eligibility criteria:
inclusion criteria: the patients must fulfill all the following criteria: * previous histologically-confirmed diagnosis of primary gbm (glioblastoma multiforme, 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 amenorrheic for at least 12 months to be considered 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).

Keywords: gross total resection convection enhanced delivery recurrent glioblastoma multiforme