Trial arm A (DCaT-RNA) = Experimental intervention: Patients in arm A receive 8 vaccinations
over a period of 2 years consisting of autologous, mature, monocyte-derived Dendritic Cells
loaded with autologous tumor RNA (20 mio DC per vaccination); cells are given via intravenous
infusions; vaccinations are followed by a 1 year observation (staging every 3 months)
Trial arm B (Observation) = Control: Patients in arm B receive standard care (observation
only with staging every 3 months)
Inclusion Criteria:
- Patients must suffer from melanoma of the uvea (stage T2, T3 and T4 [AJCC TNM grading
2009]).
- Uveal melanoma must be resected and display a monosomy for chromosome 3 (will be
determined by a validated qualitative analysis of loss of heterozygosity). Tumor
material has to be stored appropriately in RNAlater solution for RNA preparation.
- The patient has to be free of detectable tumor at the time point of study enrollment
(adjuvant setting), as assessed by clinical inspection, abdominal sonography, chest
X-ray and evaluation of the tumor-marker S-100..
- Patients must have a WHO performance status of 0, 1 or 2 and must be in stable medical
condition.
- Patients must be between 18 and 75 years old and must be able and willing to give
informed consent.
- Women of child-bearing age must have a negative pregnancy test, and must oblige to use
effective contraception until at least 4 weeks after the last vaccination.
- Patients must be willing to get hospitalized for at least 4 hours following
vaccination(s), and to cooperate for the whole period of the trial.
- Patients must have fully recovered from surgery.
- Signed informed consent
Exclusion Criteria:
- Any other major serious illness [e.g. active systemic infections, immunodeficiency
disease, clinically significant heart disease, respiratory disease, bleeding
disorders, cancer etc.] or a contraindication to leukapheresis.
- Evidence for HIV-1, HIV -2, HTLV-1, HBV, or HCV infection.
- Active autoimmune disease (such as but not limited to Lupus erythematosus, autoimmune
thyroiditis or uveitis, multiple sclerosis, inflammatory bowel disease). Vitiligo and
pathological laboratory results (autoantibodies) without clinical symptoms are,
however, not an exclusion criterion.
- Previous splenectomy or radiation therapy to the spleen.
- Patients with organ allografts.
- Concomitant treatment with chemotherapy, immunotherapy, any investigational drug and
paramedical substances. Patients may receive concomitant medications to control
symptoms such as analgetics, antihypertensive medication, etc.
- History of other active malignant neoplasm within the preceding 5 years (excluding
non-melanoma skin cancer or carcinoma in situ of the cervix).
- Organic brain syndrome or significant psychiatric abnormality which would impede
informed consent and / or AND preclude participation in the full protocol and follow
up.
- Positive pregnancy test / Pregnancy or lactation. If pregnancy occurs during the
course of the trial to female patients in arm A or B, the patient has to be excluded.
- Detection of metastases. If uveal melanoma metastases appear during the course of the
trial, the patient has to be excluded.
- Lack of compliance of the patient.
