A Phase I/II Study of High-Dose Calcitriol in Combination With Temozolomide for Patients With Metastatic 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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of high-dose calcitriol
Determine the maximum tolerate dose of high-dose calcitriol when administered with temozolomide in patients with metastatic melanoma for up to 12 months
Up to 12 months
Timothy M. Kuzel, MD
Robert H. Lurie Cancer Center
United States: Food and Drug Administration
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|