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 @ 9:54 PM
Ignite Modification Date:
2025-12-24 @ 9:54 PM
NCT ID:
NCT00077532
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed stage IV melanoma
* Clinically evaluable or measurable disease
* No mucosal or ocular melanoma
PATIENT CHARACTERISTICS:
Age
* 16 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 6 months
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL
* Hematocrit ≥ 28%
* WBC ≥ 2,500/mm\^3
Hepatic
* AST ≤ 3 times upper limit of normal (ULN)
* Bilirubin ≤ ULN (\< 3 mg/dL for patients with Gilbert's syndrome)
* Hepatitis B surface antigen negative
* Hepatitis C virus antibody negative
Renal
* Creatinine \< 2 mg/dL
Immunologic
* HIV negative
* No history of any of the following:
* Inflammatory bowel disease
* Regional enteritis
* Connective tissue disorders (e.g., systemic lupus erythematosus)
* Rheumatoid arthritis
* Autoimmune inflammatory eye disease
* Sjögren's syndrome
* Inflammatory neurologic disorder (e.g., multiple sclerosis)
* No active infection
* No active autoimmune disease that may cause life-threatening symptoms or severe organ/tissue damage
* Vitiligo, autoimmune thyroiditis, or skin rashes associated with prior therapy are allowed if patient has recovered to grade 1 or less toxicity
* No systemic hypersensitivity to study agents
* Prior local reaction (e.g., delayed hypersensitivity or glaucomatous reactions) to Montanide ISA-51 or gp100 injections allowed
* No autoimmune disease requiring active therapy with any form of steroid or immunosuppressant
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No concurrent underlying medical condition that would preclude study participation
* 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
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
* Prior therapy with gp100 peptides or any other immunotherapy allowed
Chemotherapy
* At least 6 weeks since prior nitrosoureas and recovered (toxicity no greater than grade 1)
* No concurrent chemotherapy
Endocrine therapy
* At least 4 weeks since prior steroids
* No concurrent systemic, inhaled, optical, or topical corticosteroids
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* At least 3 weeks since prior systemic therapy for melanoma and recovered (toxicity no greater than grade 1)
* No concurrent immunosuppressive agents (e.g., cyclosporine)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00077532
Study Brief:
Protocol Section:
NCT00077532