CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 120 enrolled
Drug / intervention
Dacarbazine +4 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/NCT01143402
NCT01143402Phase 2Completed

Randomized Phase II Trial of Temozolomide Versus Hyd-Sulfate AZD6244 [NSC 748727] in Patients With Metastatic Uveal Melanoma

National Cancer Institute (NCI)·interventional·Posted Jun 14, 2010·Updated Jul 26, 2017

In Brief

A Phase 2 clinical trial evaluating Dacarbazine, Laboratory Biomarker Analysis, and 3 other interventions for Iris Melanoma and 5 related conditions. Completed, enrolled 120 participants across 33 sites in 2 countries.

Detailed Summary

This randomized phase II trial studies temozolomide to see how well it works compared to selumetinib in treating patients with melanoma of the eye that has spread to other places in the body. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether temozolomide is more effective than selumetinib in treating melanoma of the eye.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 14, 2010
Enrollment StartJun 1, 2010
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 16.1 years ago

Interventions

Dacarbazinedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Quality-of-Life Assessmentother

Ancillary studies

Selumetinibdrug

Given PO

Temozolomidedrug

Given PO