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 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT00101166
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed stage IIIC or stage IV melanoma
* Measurable disease
* Age 18 or older
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* No radiation therapy within 2 weeks prior to first vaccine administration
* No chemotherapy within 4 weeks prior to first vaccine administration
* No steroid therapy within 4 weeks prior to first vaccine administration
* No surgery within 10 days prior to first vaccine administration
* Patient's written informed consent
* Patient's ability to comply with the visit schedule and assessments required by the protocol
* Adequate organ function (measured within a week of beginning treatment):
* White blood count (WBC) \> 3,000/mm\^3 and absolute neutrophil count (ANC) \>1500/mm\^3
* Platelets \> 100,000/mm\^3
* Hematocrit \> 25% and Hgb \> 8 g/dL
* Bilirubin \< 2.0 mg/dL
* Creatinine \< 2.0 mg/dL, or creatinine clearance \> 60 mL/min
Exclusion Criteria:
* Symptomatic or untreated brain metastasis
* Any serious ongoing infection
* Current corticosteroid or other immunosuppressive therapy
* Any other pre-existing immunodeficiency condition (including known HIV infection)
* Pregnant or lactating women -- Patients in reproductive age must agree to use contraceptive methods for the duration of the study (\*A pregnancy test will be obtained before treatment)
* ECOG performance status of 2, 3, or 4
* Any second active primary cancer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00101166
Study Brief:
Protocol Section:
NCT00101166