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Clinical Trial Name - Treatment With Intravitreal Avastin for Large Uveal Melanomas
| Original Study ID : 07-040 |
| NCT ID : NCT00596362 |
| 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. |
| Source : Memorial Sloan-Kettering Cancer Center |
| Overall Status : Completed |
| Start Date : April 2007 |
| End Date : June 2008 |
| Completion Date : June 2008 |
| Official Title : N/A |
| Phase : Interventional |
| Study Design : Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Enrollment : 10 |
| Verification Date : June 2008 |
| First Received Date : January 8, 2008 |
| Trial 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 : Both |
| Minimum Age : 18 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Memorial Sloan Kettering Cancer Center |
| City : New York |
| State : New York |
| Zip Code : 10065 |
| Country : United States |
| OutComes |
| Primary OutComes |
| Measure : 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 |
| Safety issue : No |
| Secondary OutComes |
| Measure : To examine the short-term safety profile of intravitreal injection of Avastin in patients with intraocular tumors. |
| Time Frame : conclusion of study |
| Safety issue : Yes |
| Interventions |
| Type : Drug |
| Name : AVASTIN |
| 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. |
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