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Dendritic Cells Plus Autologous Tumor RNA in Uveal Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01983748
Recruitment Status : Active, not recruiting
First Posted : November 14, 2013
Last Update Posted : December 2, 2022
Sponsor:
Collaborators:
University Hospital Lübeck
University Hospital Munich
Universitätsklinikum Hamburg-Eppendorf
University Hospital Homburg/Saar
Universitätsklinikum Köln
University Hospital Tuebingen
University Hospital, Essen
Wuerzburg University Hospital
Information provided by (Responsible Party):
PD Dr. med. univ. Beatrice Schuler-Thurner, University Hospital Erlangen

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.


Condition or disease Intervention/treatment Phase
Uveal Melanoma Biological: Autologous Dendritic Cells loaded with autologous Tumor RNA Phase 3

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2014
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : December 2023


Arm Intervention/treatment
Experimental: A
Biological/Vaccine; Autologous Dendritic Cells loaded with autologous Tumor RNA
Biological: Autologous Dendritic Cells loaded with autologous Tumor RNA
No Intervention: B
Control, Standard of care, which is clinical control every 3 months



Primary Outcome Measures :
  1. Prolongation of Overall survival [ Time Frame: Assessment every 3 months ]
    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, followed by telephone interviews.


Secondary Outcome Measures :
  1. Prolongation of disease free survival [ Time Frame: Assessment every 3 months ]
    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


Other Outcome Measures:
  1. Assessment for induction of immune responses [ Time Frame: The induction of immune responses will be researched in selected patients (in a minimum of 15 survivors per trial arm) 2 years after randomization. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01983748


Locations
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Germany
Dept. of Dermatology, University Hospital
Erlangen, Bayern, Germany, 90154
University Hospital Department of Ophtalmology
Erlangen, Bayern, Germany, 91054
University Hospital Department of Ophtalmology
Würzburg, Bayern, Germany, 97080
Städtisches Klinikum
Dessau, Germany, 06847
University Hospital Department of Ophtalmology
Essen, Germany, 45122
University Hospital Department of Ophtalmology
Homburg/Saar, Germany, 66421
University Hospital Department of Ophtalmology
Lübeck, Germany, 23538
University Hospital Department of Ophtalmology
Tübingen, Germany, 72076
Sponsors and Collaborators
University Hospital Erlangen
University Hospital Lübeck
University Hospital Munich
Universitätsklinikum Hamburg-Eppendorf
University Hospital Homburg/Saar
Universitätsklinikum Köln
University Hospital Tuebingen
University Hospital, Essen
Wuerzburg University Hospital
Investigators
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Principal Investigator: Beatrice Schuler-Thurner, MD University Hospital Erlangen
Publications:
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Responsible Party: PD Dr. med. univ. Beatrice Schuler-Thurner, Coordinating Investigator, University Hospital Erlangen
ClinicalTrials.gov Identifier: NCT01983748    
Other Study ID Numbers: DERMA-ER-DC 08
First Posted: November 14, 2013    Key Record Dates
Last Update Posted: December 2, 2022
Last Verified: November 2022
Keywords provided by PD Dr. med. univ. Beatrice Schuler-Thurner, University Hospital Erlangen:
Uveal Melanoma, Monosomy 3
Additional relevant MeSH terms:
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Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases