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 @ 3:52 PM
Ignite Modification Date:
2025-12-24 @ 3:52 PM
NCT ID:
NCT00658892
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed melanoma
* Stage IV disease (M1a and M1b only)
* Measurable disease according to RECIST criteria
* HLA-A2 positive
* Must have IgA in serum (any concentration)
* No known standard therapy for this disease that is potentially curative or proven capable of extending life expectancy
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Hemoglobin ≥ 10.0 g/dL
* Platelet count ≥ 75,000/mm\^3
* AST ≤ 5 times upper limit of normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to provide informed consent
* Agrees to return to Mayo Clinic Rochester for follow-up
* Agrees to participate in the mandatory translational research component of the study
* No uncontrolled or current infection
* No known immune deficiency
* No B or AB blood grouping
PRIOR CONCURRENT THERAPY:
* More than 4 weeks since prior chemotherapy and recovered
* More than 4 weeks since prior biologic therapy
* No concurrent immunosuppressive therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00658892
Study Brief:
Protocol Section:
NCT00658892