Pilot Study of IFN α2b for Melanoma Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Pittsburgh
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00871533
First received: March 26, 2009
Last updated: May 5, 2014
Last verified: May 2014
  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:


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 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
REGIONAL PEG IFN MAINTENANCE: Regional PEG IFN-a2b given subcutaneously at "MAINTENANCE" dose level. (This arm has completed enrollment; non-evaluable subjects as defined in section 9.5 may be replaced at any point during study.
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
No intervention / no injection control.
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 IFN INDUCTION: System PEG IFN-a2b given subcutaneously at "INDUCTION" dose level
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 HDI MAINTENANCE: Regional HDI given subcutaneously at "MAINTENANCE" dose level per standard HDI regimen
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
HDI Induction: Systemic HDI given intravenously at "INDUCTION" dose level per the standard HDI regimen.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 5, 2014
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
Peginterferon alfa-2b
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014