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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.
- Determine the maximum tolerate dose of high-dose calcitriol when administered with temozolomide in patients with metastatic melanoma.
- Assess toxicity of seven-day on/seven-day off temozolomide in combination with high-dose calcitriol.
- Determine tumor response and time to progression.
- Investigate the relationship between vitamin D-receptor gene polymorphisms and tumor response.
OUTLINE: This is a dose-escalation study of calcitriol followed by a phase II study.
- 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.
PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.
Primary Purpose: Treatment
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:45:44-0400
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