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:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT00084656
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed melanoma
* Stage III (≥ 3 positive lymph nodes) or stage IV disease
* Mucosal or ocular melanoma allowed
* Completely resected within the past 6 months
* Patients with stage III resected melanoma rendered free of disease may have failed, been ineligible for, or refused prior treatment with interferon alfa
* Positive staining of tumor tissue for at least one of the following:
* Antibody HMB-45 for gp100
* Antibody HMB-45 for tyrosinase
* Antibody HMB-45 for MART-1
* HLA-A\*0201 positive by DNA allele-specific polymerase chain reaction assay
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* At least 6 months
Hematopoietic
* WBC ≥ 2,500/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hematocrit ≥ 30%
* Hemoglobin ≥ 10 g/dL
Hepatic
* AST ≤ 3 times upper limit of normal (ULN)\*
* Bilirubin ≤ ULN\* (\< 3.0 mg/dL for patients with Gilbert's syndrome)
* No significant hepatic disease that would preclude study participation
* Hepatitis B surface antigen negative
* Hepatitis C antibody negative NOTE: \* Unless attributable to disease
Renal
* Creatinine ≤ 2.0 mg/dL
* No significant renal disease that would preclude study participation
Cardiovascular
* No significant cardiac disease that would preclude study participation
Pulmonary
* No significant pulmonary disease that would preclude study participation
Immunologic
* No history of any of the following:
* Inflammatory bowel disease or any other autoimmune bowel disease
* Systemic lupus erythematosus
* Rheumatoid arthritis
* Autoimmune ocular disease
* No systemic hypersensitivity to Montanide ISA-51 or any vaccine component
* No active infection requiring therapy
* HIV negative
Other
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
* No significant gastrointestinal disease that would preclude study participation
* No significant psychiatric disease that would preclude study participation
* No other medical condition that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 4 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010)
* No prior gp100 antigen, MART-1 antigen, or tyrosinase peptide
* At least 4 weeks since prior immunotherapy for melanoma and recovered
* No other concurrent immunotherapy
Chemotherapy
* At least 4 weeks since prior chemotherapy for melanoma (6 weeks for nitrosoureas) and recovered
* No concurrent chemotherapy
Endocrine therapy
* At least 4 weeks since prior hormonal therapy for melanoma and recovered
* At least 4 weeks since prior systemic, inhaled, or topical corticosteroids
* No concurrent systemic, inhaled, or topical corticosteroids
Radiotherapy
* At least 4 weeks since prior radiotherapy for melanoma and recovered
Surgery
* See Disease Characteristics
* At least 4 weeks since prior surgery for melanoma and recovered
Other
* No concurrent immunosuppressive agents (e.g., cyclosporine and its analog)
* Concurrent analgesic therapy allowed provided the dose is stable for the past 14 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00084656
Study Brief:
Protocol Section:
NCT00084656