Misonidazole and radiotherapy to treat malignant glioma: A phase II trial of the radiation therapy oncology group

Abstract Fifty-four patients with Grade III or IV malignant glioma were treated with the hypoxic-cell radiosensitizer misonidazole, and radiation therapy (RT) in a Phase II trial of the Radiation Therapy Oncology Group (RTOG). The median survival was 39 weeks. Toxicity was acceptable. Almost all toxicities were reversible and self-limited. The were no significant changes in hematologic, hepatic or renal parameters. The median survival obtained is similar to the results with conventional radiotberapy. A Phase III trial is under way comparing standard radiation and BCNU chemotherapy (1,3-bis (2-chloroethyl)-1-nitrosourea) with sensitized radiation and chemotherapy (RT + misonidazole + BCNU). Additive toxicity between misonidazole and BCNU was not observed in a pilot group.