Investigative Trial of Interferon Alpha-2b To Shrink Cancer of the Eye
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
|Official Title:||Exploratory Trial of Interferon Alpha-2b in Neoadjuvant Treatment of Ocular Melanoma|
- Evidence of anti-melanoma natural killer cell boost [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2007|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Receives 1 dose of Pegylated Interferon
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.
Placebo Comparator: II
Patients will receive placebo.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00621439
|Principal Investigator:||Hans Grossniklaus, MD||Emory University|