A Phase I/II Study of High-Dose Calcitriol in Combination With Temozolomide 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