Treatment With Intravitreal Avastin for Large Uveal Melanomas - Full Text View

Purpose

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.

Condition	Intervention
Uveal Melanoma	Drug: AVASTIN

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Neoadjuvant Treatment With Intravitreal Avastin for Large Uveal Melanomas

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Bevacizumab

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To examine the short-term safety profile of intravitreal injection of Avastin in patients with intraocular tumors. [ Time Frame: conclusion of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10
Study Start Date:	April 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 AVASTIN	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.

Arms

Assigned Interventions

Experimental: 1

AVASTIN

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596362

Locations

United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	David Abramson, M.D, Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00596362 History of Changes
Other Study ID Numbers:	07-040
Study First Received:	January 8, 2008
Last Updated:	June 5, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Melanoma
Eye
Avastin

Additional relevant MeSH terms:

Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site

Eye Diseases
Uveal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013