Further clinical experiences of a phase I study with the hypoxic cell radiosensitizer misonidazole.

Since April 1976 we have performed clinical investigations with multiple doses of the hypoxic cell radiosensitizer misonidazole in 21 patients. A significant side effect of the drug was the development of peripheral sensory neuropathies in 13 patients (8 mild, 5 severe) and of a transient acute organic psychosyndrome in 2 of the 5 patients with a severe polyneuropathy. The severity of the polyneuropathies is related to the total dose of misonidazole and the overall time of drug administration. Treatment schedules designed to obtain the desired sensitizing effect without neurological side effects are under investigation.