Dendritic Cells Plus Autologous Tumor RNA in Uveal Melanoma

  • STATUS
    Recruiting
  • End date
    Dec 9, 2023
  • participants needed
    200
  • sponsor
    University Hospital Erlangen
Updated on 9 May 2021
Investigator
Schuler-Thurner Beatrice, MD
Primary Contact
University Hospital Department of Ophtalmology (8.7 mi away) Contact
+11 other location
metastasis
therapeutic autologous dendritic cells

Summary

Patients suffering from uveal melanoma (typed positive for monosomy 3 and without evidence for metastases) will be vaccinated over a period of 2 years with Dendritic Cell loaded with autologous Tumor RNA.

200 patients will be included. The Trial is an open multicenter Phase III Trial.

Description

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)

Details
Condition Uveal Melanoma
Treatment Autologous Dendritic Cells loaded with autologous Tumor RNA
Clinical Study IdentifierNCT01983748
SponsorUniversity Hospital Erlangen
Last Modified on9 May 2021

Eligibility

Yes No Not Sure

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
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