A phase II study of intravenously-administered methyl CCNU in the treatment of advanced sarcomas

✍ Scribed by Paul Chang; Marshall A. Levine; Peter H. Wiernik; Michael D. Walker

• Publisher: John Wiley and Sons
• Year: 1976
• Tongue: English
• Weight: 392 KB
• Volume: 37
• Category: Article
• ISSN: 0008-543X
• DOI: 10.1002/1097-0142(197602)37:2<615::aid-cncr2820370202>3.0.co;2-2

✦ Synopsis

Thirty-two patients with advanced, inoperable nonhematologic soft-tissue and osseous sarcomas were treated with Methyl CCNU administered via controlled intravenous infusion in doses of 130-170 mg/m2 every 6 weeks in a Phase I1 trial. All 28 evaluable patients were no longer responsive to adriamycin. Greater than 50% tumor regression was seen in one of two patients with chondrosarcoma and one of five patients with rliabdomyosarcoma. Less than 50% tumor regression occurred in one of five patients with rhabdomyosarcoma, one of two patients with malignant giant cell tumor, and one of three patients with malignant fibrous histiocytoma. Stabilization of previously advancing disease occurred in two of seven patients with leiomyosarcoma. The drug preparation was well tolerated. Nausea and vomiting occurring in three of 32 patients. Major toxicity was myelosuppression, characterized chiefly by thrombocytopenia with lesser degrees of leukopenia. This drug preparation appears to have minimal activity in this group of tumors.

Cancer 37:615-619, 1976. HE NITROSOUREA DERIVATIVES WERE FIRST T synthesized in the early 1960's. As a group they have demonstrated significant anti tumor activity against a wide variety of animal tumor models. I-(2-Chlorethyl)-3-(4-methyl-cyclo- hexy1)-1-nitrosourea (Methyl CCNU), moreover, has been found to be unique among the nitrosoureas and most cancer chemotherapeutic agents because it shows a high degree of effectiveness against the Lewis lung tumor, a slow growing, low growth fraction neoplasm