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Prospective Study of Melastatin Expression in Predicting the Risk for Developing Local Regional Metastases of Primary Melanoma


N/A
18 Years
N/A
Not Enrolling
Both
Cutaneous Melanoma

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Trial Information

Prospective Study of Melastatin Expression in Predicting the Risk for Developing Local Regional Metastases of Primary Melanoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Primary Purpose: Diagnostic

Outcome Measure:

Correlation of melastatin expression and involvement of local regional lymph nodes by pathology prospectively

Safety Issue:

No

Principal Investigator

F. Stephen Hodi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000257230

NCT ID:

NCT00049010

Start Date:

September 2002

Completion Date:

October 2009

Related Keywords:

  • Cutaneous Melanoma
  • stage I melanoma
  • stage II melanoma
  • Melanoma
  • Skin Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Chicago Cancer Research CenterChicago, Illinois  60637
Rhode Island HospitalProvidence, Rhode Island  02903
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Fairview University Medical Center - University CampusMinneapolis, Minnesota  55455
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Miriam Hospital at LifespanProvidence, Rhode Island  02906
Brigham and Women's HospitalBoston, Massachusetts  02115
St. Luke's HospitalCedar Rapids, Iowa  52402
Mercy Regional Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403
Kingsbury Center for Cancer Care at Cheshire Medical CenterKeene, New Hampshire  03431
Charles R. Wood Cancer Center at Glens Falls HospitalGlens Falls, New York  12801
Community General Hospital of Greater SyracuseSyracuse, New York  13215
Wayne Radiation OncologyGoldsboro, North Carolina  27534
Wilson Medical CenterWilson, North Carolina  27893-3428
Mountainview MedicalBerlin, Vermont  05602
Danville Regional Medical CenterDanville, Virginia  24541
Commonwealth Hematology-Oncology P.C. - WorcesterWorcester, Massachusetts  01605
Roper St. Francis Cancer Center at Roper HospitalCharleston, South Carolina  29401
Iowa Blood and Cancer CareCedar Rapids, Iowa  52402
Capital Region Cancer CenterJefferson City, Missouri  65101