Dendritic Cells Plus Autologous Tumor RNA in Uveal Melanoma

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Brief Title

Dendritic Cells Plus Autologous Tumor RNA in Uveal Melanoma

Official Title

A NON-COMMERCIAL, MULTICENTER, RANDOMIZED, TWO-ARMED, OPEN-LABEL PHASE III STUDY TO EVALUATE THE ADJUVANT VACCINATION WITH TUMOR RNA-LOADED AUTOLOGOUS DENDRITIC CELLS VERSUS OBSERVATION OF PATIENTS WITH RESECTED MONOSOMY 3 UVEAL MELANOMA

Brief 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.
    

Detailed 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)
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Prolongation of Overall survival

Secondary Outcome

 Prolongation of disease free survival

Condition

Uveal Melanoma

Intervention

Autologous Dendritic Cells loaded with autologous Tumor RNA

Study Arms / Comparison Groups

 A
Description:  Biological/Vaccine; Autologous Dendritic Cells loaded with autologous Tumor RNA

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

200

Start Date

June 2014

Completion Date

December 2023

Primary Completion Date

June 2023

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Beatrice Schuler-Thurner, MD, 0049 9131 85, [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT01983748

Organization ID

DERMA-ER-DC 08


Responsible Party

Principal Investigator

Study Sponsor

University Hospital Erlangen

Collaborators

 University Hospital Lübeck

Study Sponsor

Beatrice Schuler-Thurner, MD, Principal Investigator, University Hospital Erlangen


Verification Date

April 2021