Back to resultsTreatment With Intravitreal Avastin for Large Uveal Melanomas
Primary Purpose
Uveal Melanoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AVASTIN
Sponsored by
About this trial
This is an interventional treatment trial for Uveal Melanoma focused on measuring Melanoma, Eye, Avastin
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.
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
AVASTIN
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00596362
First Posted
January 8, 2008
Last Updated
May 16, 2016
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00596362
Brief Title
Treatment With Intravitreal Avastin for Large Uveal Melanomas
Official Title
Neoadjuvant Treatment With Intravitreal Avastin for Large Uveal Melanomas
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveal Melanoma
Keywords
Melanoma, Eye, Avastin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
AVASTIN
Intervention Type
Drug
Intervention Name(s)
AVASTIN
Intervention Description
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 Outcome Measure Information:
Title
The Response of Intravitreal Avastin in Causing a Clinically Significant Reduction in Uveal Melanoma Tumor Size (Base Height and Volume).
Description
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
Time Frame
At conclusion of study, up to 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Abramson, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
Treatment With Intravitreal Avastin for Large Uveal Melanomas
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