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Dendritic Cells Plus Autologous Tumor RNA in Uveal Melanoma

Sponsor
University Hospital Erlangen (Other)
Overall Status
Recruiting
CT.gov ID
NCT01983748
Collaborator
University Hospital Lübeck (Other), University Hospital Munich (Other), Universitätsklinikum Hamburg-Eppendorf (Other), University Hospital Homburg/Saar (Other), Universitätsklinikum Köln (Other), University Hospital Tuebingen (Other), University Hospital, Essen (Other), Wuerzburg University Hospital (Other)
200
Enrollment
8
Locations
2
Arms
114
Duration (Months)
25
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • 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)

Study Design

Study Type:
Interventional
Anticipated 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 :
Jun 1, 2014
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Prolongation of Overall survival [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 [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 [The induction of immune responses will be researched in selected patients (in a minimum of 15 survivors per trial arm) 2 years after randomization.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Dept. of Dermatology, University Hospital Erlangen Bayern Germany 90154
2 University Hospital Department of Ophtalmology Erlangen Bayern Germany 91054
3 University Hospital Department of Ophtalmology Würzburg Bayern Germany 97080
4 Städtisches Klinikum Dessau Germany 06847
5 University Hospital Department of Ophtalmology Essen Germany 45122
6 University Hospital Department of Ophtalmology Homburg/Saar Germany 66421
7 University Hospital Department of Ophtalmology Lübeck Germany 23538
8 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

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

Study Documents (Full-Text)

None provided.

More Information

Publications

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:
Nov 14, 2013
Last Update Posted:
Apr 28, 2021
Last Verified:
Apr 1, 2021
Keywords provided by PD Dr. med. univ. Beatrice Schuler-Thurner, Coordinating Investigator, University Hospital Erlangen
Uveal Melanoma, Monosomy 3
Additional relevant MeSH terms:
Melanoma
Uveal Neoplasms

Study Results

No Results Posted as of Apr 28, 2021