Phase I/II Study of High-Dose Calcitriol Plus Temodar for Patients With Metastatic Melanoma

Inclusion Criteria: Histologically confirmed malignant melanoma Any primary tumor site Stage IV disease CNS metastases allowed Measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension as ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan Must have had at least 1 prior systemic therapy Negative pregnancy test Fertile patients must use effective contraception Patients with no prior systemic therapy are eligible provided they are not candidates for high-dose interleukin-2 Recovered from all toxic effects of prior therapy More than 4 weeks since prior and no concurrent radiotherapy, chemotherapy, or immunotherapy More than 4 weeks since prior and no concurrent radiotherapy, chemotherapy, or immunotherapy Fertile patients must use effective contraception Exclusion Criteria: Life expectancy less than 4 months known HIV positivity evidence of active infection requiring antibiotic therapy other malignancy within the past 5 years except surgically resected basal cell or squamous cell skin cancer significant medical disease which, in the opinion of the investigator, may interfere with study completion pregnant or nursing Negative pregnancy test prior temozolomide or dacarbazine investigational agent within 4 weeks prior to study entry concurrent magnesium-containing antacids, digitalis, bile-resin binding drugs, or calcium supplements