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Treatment With Intravitreal Avastin for Large Uveal Melanomas

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ClinicalTrials.gov Identifier: NCT00596362
Recruitment Status : Completed
First Posted : January 17, 2008
Results First Posted : April 14, 2015
Last Update Posted : June 17, 2016
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

January 8, 2008
January 17, 2008
March 31, 2015
April 14, 2015
June 17, 2016
April 2007
June 2008   (Final data collection date for primary outcome measure)
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
To Examine the Response of Intravitreal Avastin in Causing a Clinically Significant Reduction in Uveal Melanoma Tumor Size (Base Height and Volume). [ Time Frame: conclusion of study ]
Complete list of historical versions of study NCT00596362 on ClinicalTrials.gov Archive Site
Not Provided
To examine the short-term safety profile of intravitreal injection of Avastin in patients with intraocular tumors. [ Time Frame: conclusion of study ]
Not Provided
Not Provided
 
Treatment With Intravitreal Avastin for Large Uveal Melanomas
Neoadjuvant 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.
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Uveal Melanoma
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.
Experimental: 1
AVASTIN
Intervention: Drug: AVASTIN
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
10
June 2008
June 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00596362
07-040
Not Provided
Not Provided
Not Provided
Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
Not Provided
Principal Investigator: David Abramson, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP