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S9431: Studying Genes and Immune Response in Tumor Samples From Patients With Locally Advanced or Metastatic Melanoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00898183
First Posted: May 12, 2009
Last Update Posted: February 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
Southwest Oncology Group
  Purpose

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This laboratory study is assessing genes and immune response in tumor samples from patients with locally advanced or metastatic melanoma.


Condition Intervention
Melanoma (Skin) Genetic: gene expression analysis Genetic: polymorphism analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cytogenetic, Molecular and Cellular Biology Studies in Metastatic Melanoma Patients, Ancillary

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Correlation of frequency of non-random cytogenetic abnormalities in regional and distant melanoma metastases with clinical outcome
  • Correlation of frequency of specific genetic alterations at either the DNA, mRNA, or protein level with clinical outcome
  • Host immunologic response to metastatic melanoma (i.e., in vivo pattern of cytokine expression consistent with specific subsets of T helper cells within melanoma deposits)
  • Variation and correlation of host immunologic response with site of metastatic disease and/or clinical outcome
  • Development of a tissue bank (peripheral blood, sera, and paraffin-embedded tumor blocks)
  • Correlation of the most prevalent gene copy alteration observed in metastatic disease with the risk of progression

Enrollment: 91
Study Start Date: November 1996
Study Completion Date: February 2007
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Characterize the frequency of non-random cytogenetic abnormalities in regional and distant melanoma metastases and explore their association with clinical outcome of patients with metastatic melanoma.
  • Characterize the frequency of specific genetic alterations at either the DNA, mRNA, or protein level and explore the association of these abnormalities with clinical outcome in these patients.
  • Characterize the host immunologic response to metastatic melanoma by determining whether the in vivo pattern of cytokine expression is consistent with specific subsets of T helper cells within melanoma deposits and to explore whether host immunologic response varies based on the site of metastatic disease and/or correlates with clinical outcome in these patients.
  • Obtain peripheral blood, sera, and paraffin embedded tumor blocks from these patients.
  • Correlate the most prevalent gene copy alteration observed in metastatic disease with the risk of progression in tissue samples from patients registered on SWOG-9035 (primary melanoma).

OUTLINE: Fresh and snap frozen tumor tissue samples are obtained from biopsy or surgical procedures in the coordinated study. Specimens undergo mRNA and DNA analysis of tumor-related genes and cytokine gene expression. Peripheral blood samples are obtained and processed for sera and mononuclear cell testing. Tumor tissue samples embedded in paraffin or on unstained slides are also obtained.

PROJECTED ACCRUAL: Approximately 120 patients will be accrued for this study within 3-4 years.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of stage III or IV metastatic melanoma

    • Concurrent enrollment on a SWOG-coordinated melanoma treatment study (within 56 days of registration on this study) OR
    • Previously enrolled on and eligible for at least 1 SWOG-coordinated melanoma study and scheduled to undergo biopsy/surgery for regional lymph node or disseminated metastatic disease OR
    • Concurrent enrollment on SWOG-9430 (FISH analysis)

PATIENT CHARACTERISTICS:

Age

  • Not specified

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • Not previously enrolled on SWOG-9431
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898183


Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Investigators
Study Chair: David M. Gustin, MD University of Chicago
Study Chair: John M. Kirkwood, MD University of Pittsburgh
  More Information

Publications:
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00898183     History of Changes
Other Study ID Numbers: CDR0000078645
SWOG-9431 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: February 15, 2013
Last Verified: February 2013

Keywords provided by Southwest Oncology Group:
stage III melanoma
stage IV melanoma
recurrent 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


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