Treatment With Intravitreal Avastin for Large Uveal Melanomas

Uveal Melanoma Clinical Trial

Official title:

Neoadjuvant Treatment With Intravitreal Avastin for Large Uveal Melanomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00596362
• Other study ID #: 07-040
• Status: Completed
• Phase: N/A
• First received: January 8, 2008
• Last updated: April 13, 2015
• Start date: April 2007
• Est. completion date: June 2008

Study information

• Verified date: April 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Melanoma
• Uveal Melanoma
• Uveal Neoplasms

Intervention

Drug:
• AVASTIN
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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Response of Intravitreal Avastin in Causing a Clinically Significant Reduction in Uveal Melanoma Tumor Size (Base Height and Volume).	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	At conclusion of study, up to 5 days	No

External Links

•   Memorial Sloan Kettering Cancer Center