Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Radboud University Medical Center
With
Dutch Cancer Society
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Augmentation of Dendritic Cell-Based Vaccines in Melanoma Patients by Depletion of Regulatory T Cells in Stage IV Melanoma Patients
