Pilot Study of IFN α2b for Melanoma Patients - Full Text View

Purpose

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.

Condition	Intervention	Phase
Melanoma	Drug: IFNα2b Drug: PEG- IFNα2b	Phase 0

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

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. [ Time Frame: 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 5 ] [ Designated as safety issue: No ]
Molecularly characterize the effect of perilesional IFN α2b and PEG IFNα2b 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. [ Time Frame: 5 ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	September 2009
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 high-dose interferon α2b (HDI) induction	Drug: IFNα2b IV injection at 20 million IU/m2. IFNα2b 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.
Experimental: 2 REGIONAL HDI MAINTANANCE	Drug: IFNα2b SC injections peri-lesionally (PL) in the vicinity of the primary, at 10 million IU/m2. IFNα2b 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.
Experimental: 3 PEG INDUCTION	Drug: PEG- IFNα2b 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.
Experimental: 4 REGIONAL PEG MAINTANANCE	Drug: PEG- IFNα2b 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.
No Intervention: 5 No intervention / no injection control

Eligibility

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871533

Contacts

Contact: Ahmad A Tarhini, MD	(412) 648-6507	tarhiniaa@upmc.edu
Contact: Kristine L Connelly, RN	(412) 623-6121	connellykl@upmc.edu

Locations

United States, Pennsylvania
UPMC Hillman Cancer Center	Recruiting
Pittsburgh, Pennsylvania, United States, 15232

Sponsors and Collaborators

University of Pittsburgh

Schering-Plough

Investigators

Principal Investigator:

Ahmad Tarhini, MD

University of Pittsburgh

More Information

No publications provided

Responsible Party:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00871533 History of Changes
Other Study ID Numbers:	08-067
Study First Received:	March 26, 2009
Last Updated:	December 12, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

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

Additional relevant MeSH terms:

Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on May 22, 2013