Metastatic Melanoma Clinical Trial
Official title:
A Phase I/II Study of High-Dose Calcitriol in Combination With Temozolomide for Patients With Metastatic Melanoma
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Calcitriol may help temozolomide kill more tumor cells by making them more sensitive to the
drug. Calcitriol may also stop the growth of melanoma by blocking blood flow to the tumor.
PURPOSE: This phase I/II trial is studying the best dose of calcitriol, the side effects of
calcitriol when given together with temozolomide, and to see how well they work in treating
patients with metastatic stage IV melanoma.
* Phase I: Patients receive oral calcitriol on days 1 and 15 and oral temozolomide on days
2-8 and 16-22. Treatment repeats every 28 days for 2 courses in the absence of unacceptable
toxicity. Responding patients continue therapy for up to 6 courses in the absence of
unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of calcitriol until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose limiting toxicity.
- Phase II: Patients receive temozolomide and calcitriol at the MTD as in phase I.
After completion of study treatment, patients are followed every 3 months.
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