Biomarkers to Predict Response to Interferon Therapy in Patients With Melanoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00897546
First received: May 9, 2009
Last updated: August 20, 2010
Last verified: December 2007
  Purpose

RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer, and may help doctors learn how well patients will respond to treatment.

PURPOSE: This laboratory study is looking at biomarkers to predict the response to interferon therapy in patients with melanoma.


Condition Intervention
Melanoma (Skin)
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Multiplex Analysis of Serum Biomarkers for Prediction Interferon Therapy Response in Melanoma Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Generation of a comprehensive multiplexed array of melanoma-associated serological markers [ Designated as safety issue: No ]
  • Changes in the profile of serological markers induced by interferon-alfa 2b therapy [ Designated as safety issue: No ]
  • Panels of serological markers with prognostic and predictive power for interferon-alfa 2b response [ Designated as safety issue: No ]

Estimated Enrollment: 1716
Detailed Description:

OBJECTIVES:

  • Generate a comprehensive multiplexed array of melanoma-associated serological markers and validate it using serum samples from patients with melanoma and healthy control participants.
  • Determine changes in the profile of serological markers induced by interferon-alfa 2b (IFN-α2b) therapy.
  • Define panels of serological markers with prognostic and predictive power for IFN-α2b therapy responses in patients with melanoma.

OUTLINE: This is a multicenter study.

Serum samples are used for multiplex analyses. Biomarkers to be assessed include cytokines, chemokines, growth factors, angiogenic and antiangiogenic molecules, matrix metalloproteases (MMPs), tissue inhibitors of MMPs (TIMPs), melanoma-associated antigens, basic fibroblast growth factor, insulin-like growth factor I and II, thrombospondin, endostatin, angiostatin, vasostatin, and vascular endothelial growth factor inhibitor.

PROJECTED ACCRUAL: A total of 1,716 samples will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of melanoma OR healthy volunteer (control)

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  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: NCT00897546

Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Elieser Gorelik, MD, PhD University of Pittsburgh
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00897546     History of Changes
Other Study ID Numbers: CDR0000489213, ECOG-E1L06T1
Study First Received: May 9, 2009
Last Updated: August 20, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent melanoma
stage IV melanoma
stage IA melanoma
stage IB melanoma
stage IIA melanoma
stage IIB melanoma
stage IIC melanoma
stage IIIA melanoma
stage IIIB melanoma
stage IIIC 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
Interferons
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 28, 2014