Clinical evaluation of 5-(3,3-dimethyl-1-triazeno)imidazole-4-carboxam-ide (NSC-45388), melphalan (NSC-8806), and hydroxyurea (NSC-32065) in the treatment of disseminated malignant melanoma.

5-(3,3-Dimethyl-1-triazeno)imidazole-4-carboxamide (NSC-45388), melphalan, and hydroxyurea were evaluated in a randomized clinical trial in which 35 patients with disseminated malignant melanoma were treated. Therapeutic results were not impressive. Objective remissions were noted in two of the 23 patients who received NSC-45388, none of the 21 who received melphalan, and none of the 24 who received hydroxyurea. Toxicity was significant but tolerable: gastrointestinal toxicity was noted in 23 of the 23 patients who received NSC-45388, 15 of the 21 who received melphalan, and 16 of the 24 who received hydroxyurea. Hematologic toxicity resulted in leukocyte counts less than 3000 cells/mm3 in seven of the 23 patients who received NSC-45388, six of the 21 who received melphalan, and 18 of the 24 who received hydroxyurea. Platelet depression, with cell counts less than 100,000 cells/mm3, was noted in five of the 23 patients who received NSC-45388, three of the 21 who received melphalan, and six of the 24 who received hydroxyurea.

RCT Entities:   Population Interventions Outcomes