Phase I/II Study of High-Dose Calcitriol Plus Temodar 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.
|Metastatic Melanoma||Dietary Supplement: calcitriol Drug: temozolomide||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of High-Dose Calcitriol in Combination With Temozolomide for Patients With Metastatic Melanoma|
- Maximum tolerated dose of high-dose calcitriol [ Time Frame: Up to 12 months ]Determine the maximum tolerate dose of high-dose calcitriol when administered with temozolomide in patients with metastatic melanoma for up to 12 months
- Assess toxicity [ Time Frame: Every 2 weeks for up to 12 months ]Assess toxicity of seven-day on/seven-day off temozolomide in combination with high-dose calcitriol for every 2 weeks for up to 12 months
- Tumor response and time to progression [ Time Frame: every 8 weeks for up to 12 months ]Determine tumor response and time to progression every 8 weeks for up to 12 months
- The relationship between vitamin D-receptor gene polymorphisms and tumor response [ Time Frame: Prestudy and at disease progression or when patient goes off study ]Investigate the relationship between vitamin D-receptor gene polymorphisms and tumor response at prestudy and at disease progression, or when patient goes off study.
|Study Start Date:||May 2005|
|Estimated Study Completion Date:||May 2019|
|Estimated Primary Completion Date:||May 2018 (Final data collection date for primary outcome measure)|
Dietary Supplement: calcitriol
The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycleDrug: temozolomide
The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle
* 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00301067
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|Study Chair:||Timothy M. Kuzel, MD||Robert H. Lurie Cancer Center|