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Sensitive RT-PCR Analysis for Melanoma Markers From Lymph Nodes and Peripheral Blood in Patients With Melanoma


N/A
N/A
N/A
Not Enrolling
Both
Melanoma (Skin)

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Trial Information

Sensitive RT-PCR Analysis for Melanoma Markers From Lymph Nodes and Peripheral Blood in Patients With Melanoma


OBJECTIVES:

- 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.

- Determine the ability of PCR-positive lymph nodes or peripheral blood to predict
relapse of disease in these patients.

- Determine the correlation of positive PCR results from peripheral blood with disease
stage.

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.

PROJECTED ACCRUAL: 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.

Inclusion 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

PATIENT CHARACTERISTICS:

Age:

- Any age

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Platelet count greater than 50,000/mm^3

- 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To determine if there is a suggestion that PCR-positive lymph nodes predict relapse of disease

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Thomas F. Gajewski, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

9308

NCT ID:

NCT00004153

Start Date:

June 1998

Completion Date:

January 2005

Related Keywords:

  • Melanoma (Skin)
  • stage I melanoma
  • stage II melanoma
  • stage III melanoma
  • stage IV melanoma
  • Melanoma

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637