Pilot Analysis of the Effects of IFN α2b Upon the Molecular Profile of Regional Lymph Nodes in Melanoma Patients With and Without Tumor-Involved Sentinel Lymph Nodes
- Primary melanoma with the following Breslow thickness and stage
- less than or equal to 2 mm
- Patients with recent (within 12 wks) biopsy of primary melanoma that has not
been widely resected will be eligible for study according to the above-specified
criteria for tumor thickness and stage.
- Age 18 years or older.
- Patients must have documented hemoglobin level of 10g/dL or higher and normal organ
function tests including BUN, Creatinine, and liver enzyme panel to include AST, ALT,
and Bilirubin. This can be drawn on the day of consent, or be documented from a
previous visit within the past 30 days
- Negative serum pregnancy test
- Subjects must have provided written, informed consent prior to any study procedures:
collection of blood and LN tissue specimens for this protocol.
- Serious illnesses, such as: cardiovascular disease (uncontrolled congestive heart
failure, hypertension, cardiac ischemia, myocardial infarction, severe cardiac
arrhythmia), bleeding disorders, autoimmune diseases, severe obstructive or
restrictive pulmonary diseases, active systemic infections, inflammatory bowel
disorders, severe renal disease.
- Any significant psychiatric disease, medical intervention, or other condition, which
in the opinion of the Principal Investigator or Co-Investigators, could prevent
adequate informed consent or compromise participation in the clinical trial.
- Active infection or antibiotics within one-week prior to study.
- Systemic steroid or other immunosuppressive therapy administered for more than 10
days within 4 weeks of enrollment.