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



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

For Condition: stage 1 melanoma,stage 2 melanoma,Stage 4 Melanoma,stage 3 melanoma
Status: Suspended
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Diagnostic procedures may improve the ability to detect the presence or recurrence of disease. PURPOSE: Diagnostic trial to detect melanoma markers in the lymph nodes or peripheral blood of patients who have melanoma.
Details: 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.
Eligibility:
Study Type:
  Interventional, Diagnostic
Minimum Age/Maximum Age: /
Genders: Both
Protocol 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 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
ThomasGajewski,  Study Chair,  University of Chicago Cancer Research Center

University of Chicago Cancer Research Center
Chicago,  Illinois,  60637
United States
 


Additional Information:
Study ID Numbers:
  CDR0000067386;  UCCRC-9308,UCCRC-CTRC-9767,NCI-G99-1620
Study Start Date: 
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004153

Other Stage 3 Melanoma Studies:
1. Dacarbazine With or Without Oblimersen (G3139) in Treating Patients With Advanced Malignant Melanoma

2. Vaccine Therapy With High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma

3. Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver

4. Interleukin-12 and Interferon alfa in Treating Patients With Metastatic Malignant Melanoma

5. Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma

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