Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Diagnostic Study to Predict the Risk of Developing Metastatic Cancer in Patients With Stage I or Stage II Melanoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Diagnostic	Closed	18 and over	NCI	CALGB-500105 NCT00049010

Objectives

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

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• See Disease Characteristics

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

Expected Enrollment

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

Outcomes

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

Relapse-free survival based on visits to medical doctor every 4 months

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.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

F. Stephen Hodi, MD, Protocol chair		Ph: 617-632-5053; 866-790-4500

Registry Information
Official Title		Prospective Study of Melastatin Expression in Predicting the Risk for Developing Local Regional Metastases of Primary Melanoma
Trial Start Date		2002-09-15
Registered in ClinicalTrials.gov		NCT00049010
Date Submitted to PDQ		2002-08-02
Information Last Verified		2006-03-15
NCI Grant/Contract Number		U10-CA31946

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