Brief Title
Treatment With Intravitreal Avastin for Large Uveal Melanomas
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.
Study Type
Interventional
Primary Outcome
The Response of Intravitreal Avastin in Causing a Clinically Significant Reduction in Uveal Melanoma Tumor Size (Base Height and Volume).
Condition
Uveal Melanoma
Intervention
AVASTIN
Study Arms / Comparison Groups
1
Description: AVASTIN
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
1
Start Date
April 2007
Completion Date
June 2008
Primary Completion Date
June 2008
Eligibility 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
David Abramson, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00596362
Organization ID
07-040
Responsible Party
Sponsor
Study Sponsor
Memorial Sloan Kettering Cancer Center
Study Sponsor
David Abramson, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center
Verification Date
May 2016