Clinical Trial: Treatment With Intravitreal Avastin for Large Uveal Melanomas

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Neoadjuvant Treatment With Intravitreal Avastin for Large Uveal Melanomas

Brief Summary: The purpose of this study is to test the safety and effectiveness of Avastin introduced into the inside of the eyeball in causing shrinkage of the uveal melanoma (tumor of the eye). Avastin is an anti-cancer drug specially designed to shrink blood vessels within tumors.

Detailed Summary:
Sponsor: Memorial Sloan Kettering Cancer Center

Current Primary Outcome: The Response of Intravitreal Avastin in Causing a Clinically Significant Reduction in Uveal Melanoma Tumor Size (Base Height and Volume). [ Time Frame: At conclusion of study, up to 5 days ]

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response, Disappearance of all target lesions; Partial Response, >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease: neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for partial response nor sufficient increase in the sum of the longest diameter of target lesions to qualify for progressive disease


Original Primary Outcome: To Examine the Response of Intravitreal Avastin in Causing a Clinically Significant Reduction in Uveal Melanoma Tumor Size (Base Height and Volume). [ Time Frame: conclusion of study ]

Current Secondary Outcome:

Original Secondary Outcome: To examine the short-term safety profile of intravitreal injection of Avastin in patients with intraocular tumors. [ Time Frame: conclusion of study ]

Information By: Memorial Sloan Kettering Cancer Center

Dates:
Date Received: January 8, 2008
Date Started: April 2007
Date Completion:
Last Updated: May 16, 2016
Last Verified: May 2016