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Vaccination With Tumor mRNA in Metastatic Melanoma - Fixed Combination Versus Individual Selection of Targeted Antigens

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: NCT00204516
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : January 16, 2013
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Thomas Eigentler, University Hospital Tuebingen

Brief Summary:
The purpose of the vaccination protocol is to induce specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigen.

Condition or disease Intervention/treatment Phase
Malignant Melanoma Biological: mRNA coding for melanoma associated antigens Drug: GM-CSF Phase 1 Phase 2

Detailed Description:
vaccination protocol to induce clinically specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigens. Half of patients is treated with mRNA coding for Melan-A, Mage-A1, Mage-A3, Survivin, GP100 and Tyrosinase. The other half of patients is treated with an individualized selection of mRNAs after analysis of overexpressed melanoma antigens in autologous tumor tissue. GM-CSF is used as an adjuvants. Phase I/II clinical trial to analyse safety and immune responses in stage III/IV melanoma patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Intradermal Vaccination of Melanoma Patients With a Fixed Combination of mRNAs Compared to an Individualized Selection After Analysis of Antigen Expression in Tumor Tissue
Study Start Date : April 2007
Actual Primary Completion Date : August 2011
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: mRNA Vacc Biological: mRNA coding for melanoma associated antigens
mRNA vaccine s.c. applied weekly

Drug: GM-CSF
Given s.c. as adjuvant drug one day after vaccine




Primary Outcome Measures :
  1. Tolerability [ Time Frame: every 4 weeks ]
    Side effects will be monitored using CTCAE criteria. Tolerability and toxicity profiles will be calculated.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • malignant melanoma stage III/IV
  • fresh frozen tumor tissue available
  • informed consent given
  • Karnofsky >= 70%

Exclusion Criteria:

  • brain metastasis
  • parallel chemotherapy
  • systemic treatment with glucocorticoids
  • other malignancies

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): NCT00204516


Locations
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Germany
Department of Dermatology, University of Tuebingen
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
German Research Foundation
Investigators
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Principal Investigator: Claus Garbe, Prof. Dr. University of Tuebingen, Department of Dermatology
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Responsible Party: Thomas Eigentler, Study Coordinator, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT00204516    
Other Study ID Numbers: RNA-Mel-03
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: January 2013
Keywords provided by Thomas Eigentler, University Hospital Tuebingen:
vaccination
mRNA
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas