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 @ 12:53 PM
Ignite Modification Date:
2025-12-24 @ 12:53 PM
NCT ID:
NCT00357461
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed stage IV melanoma
* HLA-A\*0201 positive disease
* Previously treated metastatic disease
* Clinically evaluable and measurable disease
* No mucosal or ocular melanoma
* No evidence of active brain metastases
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* WBC ≥ 2,500/mm³
* Absolute neutrophil count ≥ 1,000/mm³
* Absolute lymphocyte count ≥ 500/mm³
* Platelet count ≥ 75,000/mm³
* Hemoglobin ≥ 9 g/dL
* Creatinine \< 2.5 mg/dL
* AST ≤ 2 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
* Bilirubin normal (\< 3.0 mg/dL if Gilbert's syndrome is present)
* Hepatitis B surface antigen negative
* HIV negativity
* No hepatitis C virus antibodies
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other prior malignancy except for any of the following:
* Adequately treated basal cell or squamous cell skin cancer
* Superficial bladder cancer
* Carcinoma in situ of the cervix
* Any other cancer from which patient has been disease free for \> 5 years
* No active immune-mediated disease requiring active therapy with any form of steroid or immunosuppressive therapy
* No documented history of any of the following:
* Inflammatory bowel disease
* Regional enteritis
* Connective tissue disorders, such as systemic lupus erythematosus
* Rheumatoid arthritis
* Immune-mediated inflammatory eye disease
* Sjögren's syndrome
* Inflammatory neurologic disorder, such as multiple sclerosis
* Any immune-mediated disease that can cause life-threatening symptoms or severe organ/tissue damage, in the opinion of the principal investigator
* History of vitiligo or immune-mediated thyroiditis allowed
* Skin rashes associated with previous therapy allowed provided patient has recovered from treatment-related toxicity to \< grade 1
* No active infection
* No systemic hypersensitivity to any of the study drugs
* History of local reactions (e.g., delayed hypersensitivity or glaucomatous reactions) to Montanide ISA-51 allowed
* No underlying medical condition that, in the opinion of the investigator, would preclude study treatment
PRIOR CONCURRENT THERAPY:
* At least 3 weeks since prior systemic treatment (6 weeks for nitrosoureas) and recovered
* No prior ipilimumab or gp100 vaccines
* More than 4 weeks since prior steroids
* No concurrent systemic or topical corticosteroids or immunosuppressive agents (e.g., cyclosporine or chemotherapy agents), including steroid enemas, inhaled steroids, or steroid eye drops
* Hormone-replacement therapy allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00357461
Study Brief:
Protocol Section:
NCT00357461