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Neoadjuvant Treatment With Intravitreal Avastin for Large Uveal Melanomas


N/A
18 Years
N/A
Not Enrolling
Both
Uveal Melanoma

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Trial Information

Neoadjuvant Treatment With Intravitreal Avastin for Large Uveal Melanomas


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To examine the response of intravitreal Avastin in causing a clinically significant reduction in uveal melanoma tumor size (base height and volume).

Outcome Time Frame:

conclusion of study

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

07-040

NCT ID:

NCT00596362

Start Date:

April 2007

Completion Date:

June 2008

Related Keywords:

  • Uveal Melanoma
  • Melanoma
  • Eye
  • Avastin
  • Melanoma
  • Uveal Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021