PHASE-I CLINICAL-TRIAL OF SPIROGERMANIUM

  • 1 January 1980
    • journal article
    • research article
    • Vol. 64  (10-1) , 1051-1056
Abstract
Spirogermanium is a new azaspirane antitumor agent, with the metal Ge substituted for a 1-C moiety in the ring structure. This drug inhibits DNA and RNA synthesis in [human cervical carcinoma] HeLa cells, is cytotoxic in vitro and has curative in vivo antitumor activity against the ascitic [rat] Walker 256 carcinosarcoma cells in rats. No hematologic toxicity was recorded during the preclinical toxicologic evaluation. The principal clinical toxic effects observed in this phase I trial were neurologic, manifested as lethargy, dizziness and ataxia; a grand mal seizure was produced after an accidental overdose. There was no evidence of hematologic, renal or hepatic toxicity. A partial response was achieved in 1 patient with a well-differentiated lymphocytic lymphoma. Phase II trials should be conducted with a dose of 50-80 mg/m2, administered 2 or 3 times per week in a 30 min i.v. infusion.