CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Temozolomide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00301067
NCT00301067Phase 2Completed
CompareCT.gov

A Phase I/II Study of High-Dose Calcitriol in Combination With Temozolomide for Patients With Metastatic Melanoma

Northwestern University·interventional·Posted Mar 10, 2006·Updated Jun 4, 2019

In Brief

A Phase 2 clinical trial evaluating Calcitriol and Temozolomide for Metastatic Melanoma. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Melanoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 10, 2006
Enrollment StartJan 30, 2005
Primary CompletionApr 5, 2012
Study CompletionJul 9, 2012
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 20.3 years ago

Interventions

Calcitrioldietary

The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle

Temozolomidedrug

The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle