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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

Phase 0
18 Years
Open (Enrolling)

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Trial Information

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

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To utilize gene-profiling analysis of regional lymph node tissue to molecularly characterize the effect of IFN α2b and PEG IFNα2b on the SLN. Endpoint: mRNA expression by gene array.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Ahmad Tarhini, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh


United States: Institutional Review Board

Study ID:




Start Date:

September 2009

Completion Date:

April 2014

Related Keywords:

  • Melanoma
  • Biochemical Marker
  • Biochemical Markers
  • Biologic Marker
  • Biologic Markers
  • Biomarkers
  • Clinical Marker
  • Clinical Markers
  • Immune Marker
  • Immune Markers
  • Immunologic Marker
  • Immunologic Markers
  • Laboratory Marker
  • Laboratory Markers
  • Marker, Biochemical
  • Marker, Biological
  • Marker, Clinical
  • Marker, Immunologic
  • Marker, Laboratory
  • Marker, Serum
  • Marker, Surrogate
  • Markers, Biochemical
  • Markers, Biological
  • Markers, Clinical
  • Markers, Immunologic
  • Markers, Laboratory
  • Markers, Serum
  • Markers, Surrogate
  • Markers, Viral
  • Serum Marker
  • Serum Markers
  • Surrogate End Point
  • Surrogate End Points
  • Surrogate Endpoint
  • Surrogate Endpoints
  • Surrogate Marker
  • Surrogate Markers
  • Viral Marker
  • Viral Markers
  • Melanoma



UPMC Hillman Cancer Center Pittsburgh, Pennsylvania  15232