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

NCT00621439 | Withdrawn

• 1 other identifier: IRB00002566
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ocular Melanoma

Keywords

ocular melanoma

Outcome Measures

Primary Outcomes (1)

• Evidence of anti-melanoma natural killer cell boost

  6 months

Study Arms (2)

I

EXPERIMENTAL

Receives 1 dose of Pegylated Interferon

Drug: Pegylated Interfon Alpha 2B

II

PLACEBO COMPARATOR

Receives placebo

Drug: Placebo

Interventions

Pegylated Interfon Alpha 2B DRUG

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.

I

Placebo DRUG

Patients will receive placebo.

II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have uveal melanoma for which enucleation is indicated, usually lesions greater than 8 mm in diameter and greater than 2 mm in thickness.
• Patients should have no evidence of metastatic disease as determined by history, physical examination, and appropriate liver injury enzymes.
• Patients should have received no prior interferon.
• Age \>18 years.
• Because of limited data on the use of pegylated interferon in patients \<18 years of age and uncertainties about possible differences in NK response, children are excluded from this study. Since ocular melanoma is rare in children this is not expected to be an issue.
• Life expectancy of greater than 3 months
• ECOG performance status of 0- 2 (Karnofsky 60% or better; see Appendix II).
• Patients must have normal organ and marrow function as defined below:
• Hgb \>/= 12.5 g/dl or hematocrit \>/= 38%
• Leukocytes \>3,000/mcL
• Absolute neutrophil count \>1,500/mcL
• Platelets\>100,000/mcL
• Total bilirubin within normal institutional limits unless patient has Gilbert's syndrome
• AST(SGOT)/ALT(SGPT) within normal institutional limits. Patients with elevated levels of either of these enzymes may be accepted if the elevations are less than or equal to 2x the institutional upper limit of normal and patient has a normal liver on CT or MRI.
• Creatinine within normal institutional limits OR Creatinine clearance \>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal

You may not qualify if:

• Patients who have had agents known to be immunosuppressive (e.g, glucocorticoids) within the 4 weeks prior to planned receipt of study drug.
• Patients receiving any other investigational agents.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study because interferon alpha has the potential for teratogenic effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with interferon, breastfeeding should be discontinued if the mother is treated with this agent.
• HIV-positive patients are ineligible because of the known immunosuppression associated with this disease.
• Patients with history of other malignancies are eligible provided that they are clinically free of metastases at the time of the study.
• Patients who have donated blood in the 56 days prior to the 500cc blood draw in this study are not eligible.

Sponsors & Collaborators

• Emory University: lead

MeSH Terms

Conditions

Uveal Melanoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Hans Grossniklaus, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: February 22, 2008
• Study Start: March 1, 2007
• Primary Completion: June 1, 2008
• Last Updated: December 2, 2013

Record last verified: 2013-11