A Phase II Trial of Temozolomide versus AZD6244 in Patients with Metastatic Uveal Melanoma

Protocol
10-053
Full Title
Randomized Phase II Trial of Temozolomide Versus Hyd-sulfate AZD6244 (NSC 748727) in Patients with Metastatic Uveal Melanoma (NCI#8443)
Purpose

Uveal melanoma is a rare type of melanoma. It is very hard to treat once it has spread to other parts of the body. Dacarbazine and interleukin-2, two drugs approved to treat advanced melanoma, sometimes work for skin melanoma, but only rarely work for uveal melanoma.

The purpose of this study is to find out if treatment with an investigational drug called AZD6244 or temozolomide (the pill form of dacarbazine) can stop metastatic uveal melanoma from growing. AZD6244 is a pill that blocks a protein called MEK. Most uveal melanomas grow because of MEK over-activity. Patients will be randomly assigned to receive AZD6244 or temozolomide.

This study is being conducted at Memorial Sloan-Kettering as well as several other sites in the United States.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic uveal melanoma that cannot be removed surgically.
  • At least 3 weeks must have passed since completion of any prior systemic therapy and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 18 or older.

For more information and to inquire about eligibility for this study, please contact Dr. Richard D. Carvajal at 646-888-4164.

Disease(s)
Melanoma
Melanoma: Melanoma of the Eye
Locations
Related Diseases