Treatment With Intravitreal Avastin for Large Uveal Melanomas

Not Applicable

Completed

• Conditions: Uveal Melanoma
• Interventions: Drug: AVASTIN

• Registration Number: NCT00596362
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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 Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2008-01-08
• Study First Submitted QC: 2008-01-08
• Study First Posted: 2008-01-17
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2015-03-31
• Results First Submitted QC: 2015-03-31
• Results First Posted: 2015-04-14
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-16
• Last Update Posted: 2016-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Patients diagnosed with large uveal melanomas who elect to undergo enucleation.
• Patients diagnosed with uveal melanomas with tumor thickness > 10 mm or basal diameter > 16 mm, as measured by ultrasound examination, funduscopic examination, or transillumination.

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Exclusion Criteria

• Cases that do not meet the above criteria for tumor size will be ineligible to participate in the study.
• Patients with history of metastatic cancer (other than melanoma).
• Patients not able to provide consent for the study.
• Patients with clinical or radiographic evidence of extraocular extension of the tumor.
• Patients with a previous history of an adverse reaction to intravitreal injection.
• Patients with a poor view of the fundus due to cataract or vitreous hemorrhage.
• Patients with intravitreal silicone oil or gas tamponade.
• Patients < 18 years of age.
• Women known to be pregnant.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AVASTIN	AVASTIN

Primary Outcome Measures

Name	Time	Method
The Response of Intravitreal Avastin in Causing a Clinically Significant Reduction in Uveal Melanoma Tumor Size (Base Height and Volume).	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

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States