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

This study has been withdrawn prior to enrollment.
(no funding- study never began)
Sponsor:
Information provided by (Responsible Party):
Hans Grossniklaus, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00621439
First received: February 11, 2008
Last updated: November 28, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Ocular Melanoma
Drug: Pegylated Interfon Alpha 2B
Drug: Placebo

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Evidence of anti-melanoma natural killer cell boost [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2007
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
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
Receives placebo
Drug: Placebo
Patients will receive placebo.

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).

  Eligibility

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

Inclusion Criteria:

  • 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
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for one year after the study drug is given. Should a woman become pregnant or suspect she is pregnant while participating in this study,she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Both men and women and members of all races and ethnic groups are eligible for this trial.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621439

Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Hans Grossniklaus, MD Emory University
  More Information

No publications provided

Responsible Party: Hans Grossniklaus, MD, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00621439     History of Changes
Other Study ID Numbers: IRB00002566
Study First Received: February 11, 2008
Last Updated: November 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
ocular melanoma

Additional relevant MeSH terms:
Eye Neoplasms
Melanoma
Neoplasms by Site
Neoplasms
Eye Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Reaferon
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Adjuvants, Immunologic
Alcohol Deterrents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 24, 2014