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 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT00940004
Eligibility Criteria:
Inclusion Criteria:
All patients:
* histologically documented evidence of melanoma
* stage III or IV melanoma according to the 2001 AJCC criteria
* HLA-A2.1 phenotype melanoma expressing gp100 (compulsory) and tyrosinase (non- compulsory)
* WHO performance status 0-1 (Karnofsky 100-70)
* life expectancy \> 3 months
* age 18-70 years
* no clinical signs or symptoms of CNS metastases
* WBC \> 3.0x109/l, lymphocytes \> 0.8x109/l, platelets \> 100x109/l, serum creatinine \< 150 µmol/l, serum bilirubin \< 25 µmol/l
* normal serum LDH (\< 450 U/l)
* expected adequacy of follow-up
* no pregnant or lactating women
* written informed consent
And in addition for Part I + II:
* stage III melanoma: radical regional lymphnode dissection is planned or performed
* stage IV melanoma: at least one unidimensional measurable target lesions according to RECIST, not previously irradiated, and no significant symptoms of disease requiring other palliative treatments
Exclusion Criteria:
* prior chemotherapy, immunotherapy or radiotherapy \< 4 weeks prior to planned vaccination or presence of treatment-related toxicity
* history of any second malignancy in the previous 5 years, with the exception of adequately treated basal cell carcinoma or carcinoma in situ of the cervix serious active infections, HbsAg or HIV positive or autoimmune diseases or organ allografts
* concomitant use of immunosuppressive drugs
* known allergy to shell fish (since it contains KLH)
* rapidly progressive disease
* any serious clinical condition that may interfere with the safe administration of DC
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00940004
Study Brief:
Protocol Section:
NCT00940004