drugset / Trial / NCT00301067

Phase I/II Study of High-Dose Calcitriol Plus Temodar for Patients With Metastatic Melanoma

NCT00301067

Non-randomizedSequentialOpen-labelTreatment

Summary

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.

Timeline

Start
2005-01-30
Primary completion
2012-04-05
Completion
2012-07-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Temozolomide Small molecule 150 mg/m2 Oral

Indications