Pilot Study of IFN α2b for Melanoma Patients

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00871533
• Other study ID #: 08-067
• Status: Terminated
• Phase: Early Phase 1
• First received: March 26, 2009
• Last updated: August 3, 2017
• Start date: September 2009
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 survival of melanoma cancer patients who have Stage IB disease (no known lymph node involvement with a tumor greater than 2 cm) is lower than patients who are Stage IA (no known lymph node involvement with a tumor less than 2 cm). Likewise, the survival rates of patients who are judged to be Stage II based on histologically positive level-one lymph nodes is often no better than that of higher stage patients who have level-two lymph node involvement. These observations suggest that micrometastases are often present in lymph nodes that are not detectable by histological assessment.

The collection of Sentinel Lymph Nodes (SLN) and non SLN material outlined in this proposal will permit both targeted and exploratory studies, without compromising the patient's diagnosis, on specimens that represent central engines of the immune response and whose function in the context of tumor progression is largely unknown.

With the advent of an array of new methodologies that utilize minimum material for both molecular and cellular assessments, acquiring up to 20% and in general the investigators anticipate the use of 5% on average of SLN and/or non SLN tissue for research purposes, may prove to be critical to understanding the impact of nodal tumor involvement on patient outcome and survival.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• IFNa2b
IV injection at 20 million IU/m2. IFNa2b IV injection will be performed every day between day -14 and day -9 (5 infusions) and also every day between day -7 and day -2 (5 infusions) for a total of 10 infusions.
• IFNa2b
SC injections peri-lesionally (PL) in the vicinity of the primary, at 10 million IU/m2. IFNa2b Injection will be performed every other day between day -14 and day -9 (3 injections) and also every other day between day -7 and day -2 (3 injections) for a total of 6 injections.
• PEG- IFNa2b
SC injection at 6mcg/kg will be performed systemically (at site that is not regional): first injection at day -14, second injection at day -7, for a total of 2 injections.
• PEG- IFNa2b
SC injections peri-lesionally (PL) in the vicinity of the primary at 3ug/kg: first injection at day -14, second injection at day -7, for a total of 2 injections.

Locations

Country	Name	City	State
United States	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Schering-Plough

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To utilize gene-profiling analysis of regional lymph node tissue to molecularly characterize the effect of IFN a2b and PEG IFNa2b on the SLN. Endpoint: mRNA expression by gene array.		5
Secondary	Quantitate putative biomarkers differentially expressed in the SLN for each active treatment group and among all active treatment groups combined. Endpoint: mRNA expression by Taqman.		5
Secondary	Molecularly characterize the effect of perilesional IFN a2b and PEG IFNa2b administered as close as possible to the primary tumor site on SLNs that are positive vs. negative for tumor micrometastases. Endpoint: mRNA expression by gene array.		5