Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT00020358
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of melanoma, including one of the following characteristics:
* Lesions at least 1.5 mm in thickness
* At least 1 positive lymph node
* Ulcerated lesion
* Local recurrence
* Metastatic lesions completely resected within the past 6 months
* Clinically disease free within the past 6 weeks
* HLA-A1, A3, A24, A31, or 0201 positive (HLA-A24 and HLA-A31 closed to accrual 11/05/01)
* No ocular or mucosal melanoma
PATIENT CHARACTERISTICS:
Age:
* 16 and over
Performance status:
* ECOG 0-1
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 3,000/mm\^3
* Platelet count at least 90,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.6 mg/dL (3.0 mg/dL in Gilbert's syndrome)
* AST and ALT less than 3 times normal
* Hepatitis B surface antigen negative
Renal:
* Creatinine no greater than 2.0 mg/dL
Cardiovascular:
* For interleukin-2 (IL-2) therapy:
* No cardiac ischemia, myocardial infarction, or cardiac arrhythmias
* Stress cardiac test required if abnormal EKG, symptoms of cardiac ischemia or arrhythmia, or older than 50 years
Pulmonary:
* For IL-2 therapy:
* No obstructive or restrictive pulmonary disease
* FEV\_1 greater than 60% predicted if prolonged history of cigarette smoking or symptoms of respiratory dysfunction
Other:
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No active systemic infections, autoimmune disease, or active primary or secondary immunodeficiency
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 3 weeks since prior systemic biologic therapy for melanoma
* No prior gp100 antigen or tyrosinase or TRP-1 peptide
* No other concurrent systemic biologic therapy for melanoma
Chemotherapy:
* At least 3 weeks since prior systemic chemotherapy and recovered
* No concurrent systemic chemotherapy for melanoma
Endocrine therapy:
* At least 3 weeks since prior systemic endocrine therapy for melanoma
* No concurrent systemic steroid therapy
Radiotherapy:
* At least 3 weeks since prior systemic radiotherapy and recovered
* No concurrent systemic radiotherapy for melanoma
Surgery:
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00020358
Study Brief:
Protocol Section:
NCT00020358