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 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 1:15 AM
NCT ID:
NCT00089193
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of melanoma
* Stage IIB, IIC, III, or IV disease
* Must express HLA-A1, -A2, or -A3
* No ocular melanoma
PATIENT CHARACTERISTICS:
Age
* 12 and over
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count \> 1,000/mm\^3
* Platelet count \> 100,000/mm\^3
* Hemoglobin \> 9 g/dL
Hepatic
* Liver function tests ≤ 2.5 times upper limit of normal (ULN)
Renal
* Creatinine ≤ 1.5 times ULN
Cardiovascular
* No New York Heart Association class III or IV heart disease
Other
* Not pregnant or nursing
* No other malignancy within the past 5 years except basal cell or squamous cell skin cancer without brain metastasis, carcinoma in situ of the breast, or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 4 weeks since prior immunotherapy
* More than 4 weeks since prior growth factors
* More than 4 weeks since prior allergy shots
* No prior vaccine therapy for melanoma or any other cancer with any of the peptides used in this study
* More than 12 weeks since prior melanoma vaccine therapy\* NOTE: \*Prior melanoma vaccine allowed only for patients with disease progression during or after administration of the vaccine
Chemotherapy
* More than 4 weeks since prior chemotherapy
Endocrine therapy
* More than 4 weeks since prior steroids
Radiotherapy
* More than 4 weeks since prior radiotherapy
Surgery
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT00089193
Study Brief:
Protocol Section:
NCT00089193