Status:
TERMINATED
Pilot Study of IFN α2b for Melanoma Patients
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Schering-Plough
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The presence of malignant cells in lymph nodes is a critical parameter in the staging of melanoma cancer patients. Assessment of lymph nodes is currently done by histopathology alone. The long-term su...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00871533
Start Date
September 1 2009
End Date
August 1 2017
Last Update
August 4 2017
Active Locations (1)
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1
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232