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Diagnostic Study to Predict the Risk of Developing Metastatic Cancer in Patients With Stage I or Stage II Melanoma
This study has been completed.

First Received on November 12, 2002.   Last Updated on February 28, 2011   History of Changes
Sponsor: Cancer and Leukemia Group B
Collaborator: National Cancer Institute (NCI)
Information provided by: Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT00049010
  Purpose

RATIONALE: Diagnostic procedures that analyze surgically-removed tumor tissue and lymph node samples may help doctors identify patients with melanoma who are at risk for developing metastatic cancer.

PURPOSE: This clinical trial is studying tumor tissue and lymph node samples to see how well they work in predicting the development of metastatic cancer in patients with stage I or stage II melanoma.


Condition Intervention
Cutaneous Melanoma
 Genetic: comparative genomic hybridization
Genetic: cytogenetic analysis
Genetic: fluorescence in situ hybridization
Other: immunohistochemistry staining method

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Diagnostic
Official Title: Prospective Study of Melastatin Expression in Predicting the Risk for Developing Local Regional Metastases of Primary Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma
U.S. FDA Resources

Further study details as provided by Cancer and Leukemia Group B:

Primary Outcome Measures:
  • Correlation of melastatin expression and involvement of local regional lymph nodes by pathology prospectively [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relapse-free survival based on visits to medical doctor every 4 months [ Designated as safety issue: No ]

Enrollment: 314
Study Start Date: September 2002
Study Completion Date: October 2009
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Correlate degree of melastatin gene expression with risk of developing local regional metastases in patients with primary stage I or II melanoma.
  • Correlate melastatin expression prospectively with event-free survival of these patients.

OUTLINE: This is a multicenter study.

Melastatin mRNA expression is determined by in situ hybridization using tissue from primary tumor and lymph nodes. Tissue is also examined by immunohistochemical staining using antibodies to S-100 and MART-1. Patients do not receive the results of these tests nor do the results influence individual therapy.

Patients are followed every 4 months for 3.5 years.

PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study within 3.5 years.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary stage I or II melanoma
  • Must be planning to undergo a sentinel lymph node biopsy or an elective lymph node dissection of an anatomic draining region from the index primary melanoma within 45 days

  • The following tissue blocks must be available:

    • Primary tumor tissue taken from region of greatest Breslow thickness
    • One of each sentinel node or one representative block from each lymph node obtained at elective lymph node dissection or therapeutic lymphadenectomy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • No other active malignancy except basal cell skin cancer, carcinoma in situ of the cervix, or history of any other primary malignancy, including primary melanoma

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049010

  Show 27 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Investigators
Study Chair: F. Stephen Hodi, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Monica M Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT00049010     History of Changes
Other Study ID Numbers: CDR0000257230, U10CA031946, CALGB-500105
Study First Received: November 12, 2002
Last Updated: February 28, 2011
Health Authority: United States: Federal Government

Keywords provided by Cancer and Leukemia Group B:
stage I melanoma
stage II melanoma

Additional relevant MeSH terms:
Melanoma
Skin Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on February 09, 2012



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