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

Alternate Title

Detection of Melanoma Markers in Lymph Nodes or Peripheral Blood of Patients With Melanoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Diagnostic	Closed	Any age	NCI	UCCRC-9308 UCCRC-CTRC-9767, NCI-G99-1620, NCT00004153

Objectives

1. Determine the feasibility of performing reverse transcriptase-polymerase chain reaction (RT-PCR) for five different tumor antigen genes using lymph node samples or peripheral blood from patients with melanoma.
2. Determine the ability of PCR-positive lymph nodes or peripheral blood to predict relapse of disease in these patients.
3. Determine the correlation of positive PCR results from peripheral blood with disease stage.

Entry Criteria

Disease Characteristics:

• Clinically proven melanoma with indication to perform sentinel lymph node biopsy or elective lymph node dissection

  OR




• Histologically proven or diagnosis highly suspicious for melanoma

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Patient Characteristics:

Age:

• Any age

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Platelet count greater than 50,000/mm³
• Hemoglobin greater than 7 g/dL

Hepatic:

• PT less than 15 sec
• PTT less than 30 sec

Renal:

• Not specified

Other:

• No psychiatric illness that precludes compliance
• No other concurrent malignancy

Expected Enrollment

A total of 30 patients for the lymph node portion and 80 patients (20 per stage of disease) for the peripheral blood portion will be accrued for this study within 3 years.

Outline

Lymph node biopsies or peripheral blood are obtained from patients. These specimens are examined by nested reverse transcriptase-polymerase chain reaction (RT-PCR) and analyzed for various tumor antigens.

Patients may choose to be told the results of this testing, but the results do not influence or change the planned therapy. Brief counseling is required to discuss the results and their potential implications.

Patients are followed for at least 2 years.

Trial Contact Information

Trial Lead Organizations

University of Chicago Cancer Research Center

Thomas Gajewski, MD, PhD, Protocol chair		Ph: 773-702-4601; 888-824-0200 Email: tgajewsk@medicine.bsd.uchicago.edu

Registry Information
Official Title		Sensitive RT-PCR Analysis for Melanoma Markers from Lymph Nodes and Peripheral Blood in Patients with Melanoma
Trial Start Date		1998-06-01
Registered in ClinicalTrials.gov		NCT00004153
Date Submitted to PDQ		1999-10-12
Information Last Verified		2004-10-12
NCI Grant/Contract Number		P30-CA14599

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