IN VITRO DRUG TESTING FOR LIMITED SCLC AND PHASE I DRUG DEVELOPMENT

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A. A protocol combining twice a day radiotherapy and VP- 16/Plat for limited stage lung cancer has been implimented. This protocol also uses in vitro drug testing of the patients own tumor to select chemotherapy agents after week 12. Seven patients have been entered on study and all patients (4/4) who have completed therapy have achieved a complete response and these 4 all continue to be cancer free at 11, 11, 10, and 6 months from starting therapy. No patients have been hospitalized for neutropenic fever or pulmonary toxicity. B. A phase I trial using dihydrolenperone, an agent identified as being active against human lung cancer by the human tumor colony forming assay (HTCFA) has been initiated. Fifteen patients have been studied at 5 dosage levels. The principal side effects have been somnolence and hypotension in all patients. Only one patient has has to stop therapy because of somnolence and none because of hypotension. Preliminary pharmacokinetic determinations show peak absorption at 3 hour and that level vary less than 50% over the 12 hours dosing interval. From this studies we conclude that the HTCFA has identified a compound with novel side effects and the maximum tolerated dose has not been reached.