Biomarkers in Patients With High-Risk Melanoma Receiving High-Dose Interferon Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00897520
First received: May 9, 2009
Last updated: December 23, 2009
Last verified: May 2008
  Purpose

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer and predict how patients will respond to treatment.

PURPOSE: This research study is looking at biomarkers in patients with high-risk melanoma receiving high-dose interferon therapy.


Condition Intervention
Melanoma (Skin)
Biological: recombinant interferon alfa
Genetic: proteomic profiling
Other: immunoenzyme technique
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: PILOT-high Throughput-protein Profiling Analysis of Sera Collected From E1694 Patients Undergoing HDI (Arm B)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Serum sample screening via high throughput protein profiling in patients undergoing therapy [ Designated as safety issue: No ]
  • Comparison of soluble factors [ Designated as safety issue: No ]
  • Comparison of pre-therapy and post-therapy serum samples [ Designated as safety issue: No ]
  • Kinetics of soluble factors' appearance, persistence, and disappearance during 12 months of therapy [ Designated as safety issue: No ]
  • Predictive significance of specific soluble factors in pre-therapy samples [ Designated as safety issue: No ]
  • Correlation of statistically significant factors with S100 and autoimmunity [ Designated as safety issue: No ]
  • Confirmation of data obtained by Luminex technology [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2007
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To screen serum specimens using a high throughput protein profiling platform that tests for the highest number of known biomarkers (detectable by antibodies) that could be predictors of response to interferon treatment, autoimmunity, and disease outcome in patients with high-risk melanoma undergoing high-dose interferon (IFNa2b) therapy .
  • To compare soluble factors across all patients at each time point (baseline and during therapy).
  • To compare pre-therapy vs post-therapy serum samples from these patients.
  • To assess the kinetics of soluble factors' appearance, persistence, and disappearance during the 12 months of therapy.
  • To assess whether the amount of specific soluble factors in the pre-therapy sample is predictive of response independent of therapy.
  • To correlate statistically significant factors with S100 and autoimmunity in these patients.
  • To confirm the data obtained with the Luminex technology.

OUTLINE: Patients are stratified according to survival (< 2 years vs > 5 years).

Blood samples collected from patients enrolled in E-1694 are analyzed using high throughput protein profiling by ELISA to compare changes in levels of putative biomarkers of interferon alfa-2b, including cytokines and paired receptors, chemokines, cell adhesion molecules, metalloproteinases, angiogenic markers, growth factors, soluble receptors, signal transduction molecules, hormones, and other biomarkers of disease and dysregulated immune processes, at baseline and during therapy.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of high-risk melanoma
  • Receiving interferon alfa-2b therapy in arm II of clinical trial E-1694

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  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: NCT00897520

Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Monica Panelli, PhD University of Pittsburgh
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00897520     History of Changes
Other Study ID Numbers: CDR0000585297, ECOG-E1694T1
Study First Received: May 9, 2009
Last Updated: December 23, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage II melanoma
stage III melanoma
stage IV melanoma

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
Interferon-alpha
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 28, 2014