A prospectively randomized study of postoperative chemotherapy with dimethyl triazeno imidazole carboxamide (DTIC) was conducted by the Central Oncology Group from 1972 until 1976. Of 174 patients operated upon for melanoma and entered into the study, 87 were randomly selected to receive DTIC, four courses in 12 months, at 4.5 mg/kg/d x 10. One-hundred-sixty-five (95%) of the cases were evaluable, including 40 high risk Stage I, 96 Stage XI, and 29 Stage 111 cases. At a median follow-up period of 2.5 years, the control group had a better median disease-free interval (40 weeks vs. 73 weeks), median survival time (103 weeks vs. 133 weeks), and percentage of patients living free of disease (28% vs. 44%) than the DTIC-treated group. While disease-free interval appeared to be improved in the 25% of patients on DTIC therapy who developed thrombocytopenia, the overall effect of postoperative DTIC therapy was apparently not beneficial (P < 0.05). Cancer 47:2556-2562, 1981. ELANOMA is a relatively uncommon tumor, ac-M counting for approximately 1.4% of the annual mortality from cancer in the United States. An estimated 9600 new cases and 4000 deaths occurred from melanoma in the United States in 1978.' In spite of the low frequency of this tumor, melanoma has evoked interest amongst oncologists because of its many unusual or unique aspects. These features include geographic and racial variations in incidence, family clusters, immunologic aspects, questions of viral presence , radiation resistance, unusually long free intervals followed by rapid progression in some patients, hormonal aspects, and reports of spontaneous remissions.2
A Phase I clinical trial of emetine hydrochloride (NSC‐33669) in adults with solid tumors was conducted using two time schedules: a. a single subcutaneous dose daily for 10 days, and b. a single subcutaneous injection every 4 days (q4d) for 10 doses. Thirty‐two patients were treated on the daily schedule with doses ranging from 1.0–2.0 mg/kg/day, and nine patients were treated in the q4d schedule with doses ranging from 1.2–2.2 mg/kg/dose. Toxicity was similar in both groups and consisted of pain at the injection site, muscle weakness and myalgia, elevations in creatine phosphokinase, and electrocardiographic abnormalities. Muscle weakness was the dose‐limiting toxicity. The maximum tolerable total dose was 10 mg/kg. No response was noted in 16 patients evaluated.
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