mitolactol and Skin-Neoplasms

Topics: Adult; Aged; Drug Evaluation; Female; Humans; Male; Melanoma; Middle Aged; Mitolactol; Neoplasm Metastasis; Skin Neoplasms

Dibromodulcitol (DBD) and BCNU were administered to 20 patients with metastatic malignant melanoma who had not received prior chemotherapy. One complete and three partial responses were noted; duration of response was short. Dose limiting toxicity was thrombocytopenia. DBD and BCNU do not appear to improve response over single agent therapy for disseminated melanoma.

Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carmustine; Drug Evaluation; Female; Humans; Male; Melanoma; Middle Aged; Mitolactol; Neoplasm Metastasis; Skin Neoplasms

Twenty-four patients were evaluated in a non-randomized study to assess the effectiveness of dibromodulcitol (DBD) in Stage IV melanoma. Patients received 100 mg/m2 of DBD orally for 35 days. The dose was escalated to 130 mg/m2 and then to 160 mg/m2 if no significant hematologic toxicity occurred. There were no objective responses, including six patients who had had no prior chemotherapy. Five patients (21%) remained stable. Median survival was 151 days. Survival favored females, nonvisceral involvement pretherapy, and patients with a disease-free interval (DFI) of greater than 1 year. None of these advantages was statistically significant. Toxicity was predominantly hematologic, but nausea, vomiting, shortness of breath, and diarrhea were also seen. Oral DBD, using this dose and schedule, does not appear efficacious in advanced disseminated melanoma.

Topics: Drug Administration Schedule; Drug Evaluation; Female; Humans; Male; Melanoma; Mitolactol; Skin Neoplasms

Twenty-six patients with disseminated malignant melanoma received an oral regimen of mitolactol and semustine (methyl-CCNU). Sixteen patients had received prior systemic therapy, and 16 had visceral involvement. There were no objective regressions among ten patients receiving the drugs as initial systemic therapy. However, one of 16 patients having prior systemic treatment did have an objective response. Hematologic and gastrointestinal toxic effects were well-tolerated.

Topics: Aged; Drug Evaluation; Drug Therapy, Combination; Female; Humans; Leukocyte Count; Leukopenia; Male; Melanoma; Middle Aged; Mitolactol; Neoplasm Metastasis; Nitrosourea Compounds; Pilot Projects; Platelet Count; Semustine; Skin Neoplasms; Thrombocytopenia