NCT00621439

Investigative Trial of Interferon Alpha-2b To Shrink Cancer of the Eye

Exploratory Trial of Interferon Alpha-2b in Neoadjuvant Treatment of Ocular Melanoma

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore whether the drug pegylated-interferon-alfa-2b (PEG-IFN) has any effect on a certain type of immune cell (called natural killer cells) in patients with eye melanoma.

Detailed description

The purpose of this study is to explore whether the drug pegylated-interferon-alfa-2b (PEG-IFN)has any effect on a certain type of immune cell (called natural killer cells) in patients with eye melanoma. Because this drug is currently being investigated for use against skin melanoma, we think this drug might have some benefit in eye melanoma as well, and that natural killer cells might be important in how the drug works. Patients who choose to take part in the study will be randomized to receive either no drug, or PEG-IFN. Four days prior to the patient's surgery to remove the eye, 50cc of blood will be drawn. Patients who are randomized to PEG-IFN will be given the drug once, 4 days prior to surgery. Blood will also be drawn on the day of surgery (50cc), 1 week after surgery (50cc), 1 month (500cc), and 6 months (50cc).

Conditions

• Ocular Melanoma

Interventions

Type	Name	Description
DRUG	Pegylated Interfon Alpha 2B	Patients will receive PEG-IFN 6 mcg/kg subcutaneously 4 days prior to surgery. Patients will be premedicated with acetaminophen 700 mb orally prior to the injection. Only one dose of drug will be given. Enucleation will follow in 4 days.
DRUG	Placebo	Patients will receive placebo.

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-06-01
• First posted: 2008-02-22
• Last updated: 2013-12-02