Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Detection of Melanoma Markers in Lymph Nodes or Peripheral Blood of Patients With Melanoma
| 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
- 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.
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 Lead Organizations
University of Chicago Cancer Research Center
 | | | ||
| Thomas Gajewski, MD, PhD, Protocol chair | |
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| Registry Information | ||
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| Official Title | Sensitive RT-PCR Analysis for Melanoma Markers from Lymph Nodes and Peripheral Blood in Patients with Melanoma | |
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| Trial Start Date | 1998-06-01 | |
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| Registered in ClinicalTrials.gov | NCT00004153 | |
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| Date Submitted to PDQ | 1999-10-12 | |
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| Information Last Verified | 2004-10-12 | |
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| NCI Grant/Contract Number | P30-CA14599 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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