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Clinical Trials with 1, 3-Bis(2-chloroethyl)-1-nitrosourea, NSC-409962¹

Laboratory of Chemical Pharmacology, National Cancer Institute, Bethesda, Maryland; Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland; Georgetown University School of Medicine, Washington, D. C.; Medical Service, Lemuel Shattuck Hospital, Boston, Massachusetts; and Roswell Park Memorial Institute, Buffalo, New York

The compound 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU) has unusual physical and chemical properties and is a highly effective anti-cancer agent in animals. Preliminary trials were conducted in 144 patients with various maligmant diseases at several dose levels and schedules.

These trials indicated that the following i.v. dose schedules were tolerable and comparable in toxicity: 250 mg/sq m in a single dose, 125 mg/sq m for 3 successive days, and 90 mg/sq m/week for 6 weeks.

Hematopoietic toxicity was dose limiting and was delayed and prolonged after drug administration. Reversible minor hepatic and renal toxicity was seen in 26% and 10% of the patients, respectively. Anti-tumor activity was noted in a variety of tumors in man.

¹ This study was undertaken by the Eastern Cooperative Group in Solid Tumor Chemotherapy (Chairman, Bruce I. Shnider) under the auspices of the Collaborative Clinical Trials Program of the National Cancer Institute. Investigations were supported by USPHS research grants from the National Cancer Institute.

² Laboratory of Chemical Pharmacology and Medicine Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, and the USPHS Hospital, Baltimore, Md.

³ Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, Md. (CA-02823).

⁴ Georgetown University School of Medicine, District of Columbia General Hospital, and Veterans Administration Hospital, Washington, D. C. (CA-02824).

⁵ Medical Service, Lemuel Shattuck Hospital, Department of Public Health, Commonwealth of Massachusetts, and the Department of Medicine, Tufts Medical School, Boston, Mass. (CA-07190).

⁶ Department of Medicine A, Roswell Park Memorial Institute, New York State Department of Health, Buffalo, N. Y. (CA-02821).

Received 5/12/65.