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Temozolomide or Selumetinib in Treating Patients With Metastatic Melanoma of the Eye

NCT01143402 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-07-26

Study results available
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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.

Conditions

  • Iris Melanoma
  • Medium/Large Size Posterior Uveal Melanoma
  • Ocular Melanoma With Extraocular Extension
  • Recurrent Uveal Melanoma
  • Small Size Posterior Uveal Melanoma
  • Stage IV Uveal Melanoma

Interventions

DRUG

Dacarbazine

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Quality-of-Life Assessment

Ancillary studies

DRUG

Selumetinib

Given PO

DRUG

Temozolomide

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Paul Chapman · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01143402 on ClinicalTrials.gov