Clinical Trials /

Dendritic Cells Plus Autologous Tumor RNA in Uveal Melanoma

NCT01983748

Description:

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.

Related Conditions:
  • Uveal Melanoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: DERMA-ER-DC 08
  • NCT ID: NCT01983748

Conditions

  • Uveal Melanoma

Interventions

DrugSynonymsArms
Autologous Dendritic Cells loaded with autologous Tumor RNAA

Purpose

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)
    

Trial Arms

NameTypeDescriptionInterventions
AExperimentalBiological/Vaccine; Autologous Dendritic Cells loaded with autologous Tumor RNA
  • Autologous Dendritic Cells loaded with autologous Tumor RNA
BNo InterventionControl, Standard of care, which is clinical control every 3 months

    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.
          
    Maximum Eligible Age:75 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Prolongation of disease free survival
    Time Frame:Clinical staging every 3 months from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
    Safety Issue:
    Description:Skin, lymph node and ophtalmological inspection , medical history, laboratory, and abdominal sonography will be performed every 3 months, chest x ray will be performed every 6 months

    Secondary Outcome Measures

    Measure:Prolongation of Overall survival
    Time Frame:Assessment every 3 months
    Safety Issue:
    Description:

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:University Hospital Erlangen

    Trial Keywords

    • Uveal Melanoma, Monosomy 3

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