Dendritic Cells Plus Autologous Tumor RNA in Uveal Melanoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University Hospital Erlangen
Sponsor:
Collaborators:
University Hospital of Berlin
University Hospital Lübeck
University Hospital Munich
University Hospital Homburg/Saar
University Hospital Tuebingen
University Hospital, Essen
Information provided by (Responsible Party):
PD Dr. med. univ. Beatrice Schuler-Thurner, University Hospital Erlangen
ClinicalTrials.gov Identifier:
NCT01983748
First received: September 17, 2013
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

Patients suffering from uveal melanoma (typed positive for monosomy 3) 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 Intervention Phase
Uveal Melanoma, Monosomy 3 Positive, no Evidence for Metastases.
Biological: Autologous Dendritic Cells loaded with autologous Tumor RNA
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital Erlangen:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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:
  • Prolongation of Overall survival [ Time Frame: Assessment every 3 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2014
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01983748

Contacts
Contact: Schuler-Thurner Beatrice, MD 0049 9131 85 ext 45833 beatrice.schuler-thurner@uk-erlangen.de
Contact: Schuler Gerold, Prof. 0049 9131 85 ext 33661 gerold.schuler@uk-erlangen.de

Locations
Germany
University Hospital Department of Ophtalmology Recruiting
Erlangen, Bayern, Germany, 91054
Contact: Harald Knorr, Prof.    0039 9131 85 ext 44728    harald.knorr@uk-erlangen.de   
Contact: Stoll Barbara, Study nurse       barbara.stoll@uk-erlangen.de   
Principal Investigator: Friedrich Kruse, Prof.         
Dept. of Dermatology, University Hospital Active, not recruiting
Erlangen, Bayern, Germany, 90154
University Hospital Department of Ophtalmology Not yet recruiting
Munich, Bayern, Germany, 80336
Contact: Annemarie Klingenstein, MD    0049 89 5160 ext 3801    annemarie.klingenstein@med.uni-muenchen.de   
Principal Investigator: Anselm Kampik, Prof.         
University Hospital Department of Ophtalmology Not yet recruiting
Würzburg, Bayern, Germany, 97080
Contact: T. Meyer Ter-Wehn, MD    0049 931 201 ext 206 28    meyer_t3@augenklinik.uni-wuerzburg.de   
Principal Investigator: Franz Grehn, Prof.         
University Hospital Department of Ophtalmology Not yet recruiting
Essen, Germany, 45122
Contact: Claudia Metz, MD    0049 201 7238 ext 3471    Claudia.Metz@uk-essen.de   
Principal Investigator: Norbert Bornfeld, Prof.         
University Hospital Department of Ophtalmology Not yet recruiting
Homburg/Saar, Germany, 66421
Contact: Anne-Marie Conigliari, Study nurse    0049 6841 16 ext 22387    Augenklinik.studienarzt@uks.eu   
Principal Investigator: Berthold Seitz, Prof.         
University Hospital Department of Ophtalmology Not yet recruiting
Lübeck, Germany, 23538
Contact: Julia Lueke, MD    0049 451 500 22 ext 11    Julia.Lueke@uk-sh.de   
Principal Investigator: Salvatore Grisanti, Prof.         
University Hospital Department of Ophtalmology Recruiting
Tübingen, Germany, 72076
Contact: Ulrike Hagemann, Study nurse    0049 7071 29837 ext 30    ulrike.hagemann@med.uni-tuebingen.de   
Contact: Daniela Suesskind, MD    0049 7071 29837 ext 30    daniela.suesskind@med.uni-tuebingen.de   
Principal Investigator: Ulrich Bartz-Schmidt, Prof.         
Principal Investigator: Daniela Süsskind, MD         
Sponsors and Collaborators
University Hospital Erlangen
University Hospital of Berlin
University Hospital Lübeck
University Hospital Munich
University Hospital Homburg/Saar
University Hospital Tuebingen
University Hospital, Essen
Investigators
Principal Investigator: Gerold Schuler, Prof. University Hospital Erlangen
  More Information

No publications provided

Responsible Party: PD Dr. med. univ. Beatrice Schuler-Thurner, Coordinating Investigator, University Hospital Erlangen
ClinicalTrials.gov Identifier: NCT01983748     History of Changes
Other Study ID Numbers: DERMA-ER-DC 08
Study First Received: September 17, 2013
Last Updated: July 10, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by University Hospital Erlangen:
Uveal Melanoma, Monosomy 3

Additional relevant MeSH terms:
Melanoma
Monosomy
Neoplasm Metastasis
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Aneuploidy
Chromosome Aberrations
Pathologic Processes
Neoplastic Processes
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on July 22, 2014