Phase II study of 1-(2-chloroethyl)-3-cyclohexyl-1-nitrosourea (CCNU; NSC-79037) in the treatment of brain tumors.

Thirty-eight patients with symptomatic recurrent primary or metastatic brain tumors were treated with 1-(2-chloroethyl)-3-cyclohexyl-1-nitrosourea (CCNU) at an initial dose of 120-130 mg/m2 with subsequent doses determined by the degree of delayed toxicity. The interval between treatments was usually 6 weeks. Two groups of patients were treated: those who had received no prior chemotherapy and those who had previously received BCNU. The response rates were 33% and 0 respectively. The major dose-limiting toxic effect was delayed depression of the white blood cell and platelet counts; this depression was not cumulative with the schedule used. Significant toxicity was encountered more frequently in the patients who had received BCNU previously. We concluded (a) that CCNU was effective against recurrent brain tumors although the results were not any better than those attainable with BCNU in a similar group of patients, and (b) that cross resistance to CCNU occurred in patients treated previously with BCNU.