CT 2001 A STAGED PHASE I STUDY OF THE TREATMENT OF MALIGNANT GLIOMA WITH G207,

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Malignant gliomas are the most common brain tumors in adults with 10,000-15,000 new cases every year. Treatments such as surgery, radiation, and chemotherapy, have extended the survival of patients with these brain tumors from 14 weeks to one year; however, the five year survival rate for one tupe of malignant glioma, glioblastoma multifome, is still 5.5% or less. Previous clinical studies have shown that single doses of G207 administered intracerebrally are well tolerated and suggest that G207 may induce tumor regression. This study is designed to evaluate the effects of G207 followed by radiation therapy in patients with progressive growth of malignant glioma after radiation and/or chemotherapy. The study design is a two stage trial. Stage 1: G207 will be administered by five stereotactic injections of 0.2 mL into regions of the tumor, followed by focal radiation therapy 24 hours post injection. A de-escalation scheme will be utilized since G207 has not shown toxicities at this level. Once the maximum tolerated dose has been established for stage 1, the protocol will be repeated at this dose level of G207 followed by gamma knife radiosurgery. Objectives of the study are as follows: To obtain safety information in patients with recurrent/progressive malignant glioma undergoing intratumoral inoculation with G207 followed by treatment with radiation therapy. Patients will be grouped into small dosing cohorts of 2-9 patients.