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Treatment With Intravitreal Avastin for Large Uveal Melanomas

Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Uveal Melanoma

Intervention: AVASTIN (Drug)

Phase: N/A

Status: Completed

Sponsored by: Memorial Sloan Kettering Cancer Center

Official(s) and/or principal investigator(s):
David Abramson, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center

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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The Response of Intravitreal Avastin in Causing a Clinically Significant Reduction in Uveal Melanoma Tumor Size (Base Height and Volume).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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. 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.

Locations and Contacts

Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States
Additional Information

Memorial Sloan Kettering Cancer Center

Starting date: April 2007
Last updated: April 13, 2015

Page last updated: August 20, 2015

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