Phase II trial of dianhydrogalactitol in metastatic malignant melanoma: a Southwest Oncology Group study.

Dianhydrogalactitol given iv in a schedule of 30 mg/m2/day for 5 consecutive days every 4 weeks was administered to 27 patients with metastatic malignant melanoma. All patients had received extensive prior therapy including chemotherapy and had progressive disease at the start of the study. Of 24 patients evaluable for response, 21 demonstrated progressive disease and three had stable disease for periods of from 4 to 11 months. No objective responses were observed. Two of the remaining three patients died 6 and 10 days after entry in the study, while the third refused to return after one drug course. Adverse effects included myelosuppression in eight patients, nausea and vomiting in five patients, and alopecia in one patient. Dianhydrogalactitol is considered to be insignificantly active in the secondary treatment of metastatic malignant melanoma at the dose and schedule studied.