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:
2025-12-26 @ 3:59 PM
Ignite Modification Date:
2025-12-26 @ 3:59 PM
NCT ID:
NCT00847106
Eligibility Criteria:
Inclusion Criteria:
1. Histologically documented evidence of melanoma.
2. Stage IV melanoma according to the 2001 AJCC criteria. \[53\] Limited tumor burden; LDH \< 2x upper limit of normal.
3. HLA-A2.1 phenotype according to lymphocyte HLA typing.
4. Expression of gp100 and/or tyrosinase on melanoma cells, as detected by immunohistochemistry, preferably on metastatic tumor, but if not available on primary tumor.
5. ECOG performance status 0-1, life expectancy \> 3 months.
6. Age 18-75 years. -
7. Written informed consent.
8. Expected adequacy of follow-up.
9. WBC \> 3.0 x 109/l, lymphocytes \> 0.8 x 109/l, platelets \> 100 x 109/l, serum creatinine \< 150 μmol/l, serum bilirubin \< 25 μmol/l.
Exclusion Criteria:
10. No clinical signs of CNS metastases, in patients with a clinical suspicion of CNS metastases CT scan of the brain should be performed to exclude this.
11. No prior chemotherapy, immunotherapy, or radiotherapy within three months before planned vaccination is allowed.
12. No previous treatment with monoclonal antibodies.
13. No concomitant use of corticosteroids or other immunosuppressive agents.
14. No history of second malignancy within the last 5 years. Adequately treated basal carcinoma of skin or carcinoma in situ of cervix is acceptable within this period.
15. No serious concomitant disease, no active infections. Specifically, patients with autoimmune disease or organ allografts, and HBsAg or HIV positive patients are excluded.
16. Patients with a known allergy to shell fish (contains KLH) are excluded.
17. Patients with asthma or severe allergic disease necessitating medication are excluded
18. No pregnant or lactating women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00847106
Study Brief:
Protocol Section:
NCT00847106