PHASE-II TRIAL OF PIRITREXIM AND DTIC USING AN ALTERNATING DOSE SCHEDULE IN METASTATIC MELANOMA

A Phase II trial was conducted in patients with metastatic malignant m elanoma with DTIC 250 mg/m(2) intravenously for 5 days alternating mon thly with Piritrexim (PTX) using an intermittent, low-dose oral admini stration schedule. PTX was administered at a starting dose of 25 mg or ally three times per day for 5 days weekly for 3 weeks followed by wee k of rest. Twenty-one patients were entered into the study. Among the 17 patients assessable for response, 1 patient had a minor response, a nd 3 patients had stable disease. No partial or complete response were observed. Toxicity was tolerable and consistent mainly of myelosuppre ssion. Using this alternating dose schedule, PTX and DTIC produced lit tle response in metastatic melanoma.