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

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00049010

Collaborator

National Cancer Institute (NCI) (NIH)

314

Enrollment

Locations

Arm

Duration (Months)

11.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Melanoma (Skin)	Genetic: comparative genomic hybridization Genetic: cytogenetic analysis Genetic: fluorescence in situ hybridization Other: immunohistochemistry staining method	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

314 participants

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

Study Start Date :

Sep 1, 2002

Actual Primary Completion Date :

Mar 1, 2006

Actual Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 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.	Genetic: comparative genomic hybridization Genetic: cytogenetic analysis Genetic: fluorescence in situ hybridization Other: immunohistochemistry staining method

Arm

Intervention/Treatment

Experimental: Group 1

Genetic: comparative genomic hybridization

Genetic: cytogenetic analysis

Genetic: fluorescence in situ hybridization

Other: immunohistochemistry staining method

Outcome Measures

Primary Outcome Measures

Relapse-free survival [Up to 3.5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Histologically documented primary AJCC stage I or II melanoma. Evidence of ulceration, vertical growth phase, regression, lymphocytic infiltration, vascular invasion, microscopic satellitosis, and mitotic rate shall be noted.
Patients planning to undergo a sentinel lymph node biopsy, or an elective lymph node dissection of an anatomic draining region from the index primary melanoma.
≥18 years of age
Patients must be registered prior to planned surgery. The surgery must be performed within 45 days following registration.
No concurrent active malignancy other than carcinoma in situ of the cervix and basal cell carcinoma of the skin, or history of any other primary malignancy including previously primary melanoma.
Tissue blocks: one of primary tumor tissue taken from region of greatest Breslow thickness. Note: If blocks cannot be sent due to institutional policy, slides may be substituted for the locks per the protocol.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
2	Iowa Blood and Cancer Care	Cedar Rapids	Iowa	United States	52402
3	St. Luke's Hospital	Cedar Rapids	Iowa	United States	52402
4	Mercy Regional Cancer Center at Mercy Medical Center	Cedar Rapids	Iowa	United States	52403
5	Massachusetts General Hospital Cancer Center	Boston	Massachusetts	United States	02114
6	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
7	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
8	Commonwealth Hematology-Oncology P.C. - Worcester	Worcester	Massachusetts	United States	01605
9	Fairview University Medical Center - University Campus	Minneapolis	Minnesota	United States	55455
10	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri	United States	65203
11	Capital Region Cancer Center	Jefferson City	Missouri	United States	65101
12	Kingsbury Center for Cancer Care at Cheshire Medical Center	Keene	New Hampshire	United States	03431
13	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756-0002
14	Charles R. Wood Cancer Center at Glens Falls Hospital	Glens Falls	New York	United States	12801
15	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
16	CCOP - Hematology-Oncology Associates of Central New York	Syracuse	New York	United States	13057
17	Community General Hospital of Greater Syracuse	Syracuse	New York	United States	13215
18	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina	United States	27534
19	Wayne Radiation Oncology	Goldsboro	North Carolina	United States	27534
20	Wilson Medical Center	Wilson	North Carolina	United States	27893-3428
21	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina	United States	27157-1096
22	Rhode Island Hospital	Providence	Rhode Island	United States	02903
23	Miriam Hospital at Lifespan	Providence	Rhode Island	United States	02906
24	Roper St. Francis Cancer Center at Roper Hospital	Charleston	South Carolina	United States	29401
25	Mountainview Medical	Berlin	Vermont	United States	05602
26	Fletcher Allen Health Care - University Health Center Campus	Burlington	Vermont	United States	05401
27	Danville Regional Medical Center	Danville	Virginia	United States	24541

Sponsors and Collaborators

Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)

Investigators

Study Chair: F. Stephen Hodi, MD, Dana-Farber Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alliance for Clinical Trials in Oncology

ClinicalTrials.gov Identifier:

NCT00049010

Other Study ID Numbers:

CALGB-500105
U10CA031946
CALGB-500105
CDR0000257230

First Posted:

Jan 27, 2003

Last Update Posted:

Jul 1, 2016

Last Verified:

Jun 1, 2016

Keywords provided by Alliance for Clinical Trials in Oncology

stage I melanoma

stage II melanoma

Additional relevant MeSH terms:

Melanoma

Study Results

No Results Posted as of Jul 1, 2016