Treatment With Intravitreal Avastin for Large Uveal Melanomas

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.

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Key information

Conditions

Uveal Melanoma Eye Diseases Eye Neoplasms Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Uveal Diseases Uveal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Avastin

Drug

a single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be given into the eye. Right after this injection, your eye will be examined by your doctor. The pressure in your eye will also be tested before and after the injection. Patients will use antibiotic drops for 5 days following the injection. Following the injection, you will have weekly examinations for four weeks in the office.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Neoadjuvant Treatment With Intravitreal Avastin for Large Uveal Melanomas

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Jan 17, 2008
Registry last updated: Jun 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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