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Intradermal Vaccination With Stabilized Tumor mRNA - a Clinical Phase I/II Trial in Melanoma Patients

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: NCT00204607
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 19, 2007
Sponsor:
Information provided by:
University Hospital Tuebingen

Brief Summary:
vaccination protocol 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 Drug: GM-CSF s.c. Phase 1 Phase 2

Detailed Description:
vaccination protocol to induce specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigen. Antigens used are Melan-A, Mage-A1, Mage-A3, Survivin, GP100 and Tyrosinase. GM-CSF is used as an adjuvans. Phase I/II clinical trial to analyse safety and immune respones in stage III/IV melanoma patients.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Induction of Specific Immune Responses Against Melanoma-Associated Antigens in Vivo by Intradermal Vaccination With Stabilized Tumor mRNA - a Clinical Phase I/II Trial
Study Start Date : July 2004
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources




Primary Outcome Measures :
  1. toxicity
  2. immune response


Information from the National Library of Medicine

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

Inclusion Criteria:

  • stage III/IV
  • fresh frozen tumor-tissue
  • age 18-75
  • informed consent given
  • Karnofsky >= 70%

Exclusion Criteria:

  • systemic glucocorticoids
  • brain metestasis
  • 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): NCT00204607


Locations
Germany
Department of Dermatology, University of Tübingen
Tübingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Claus Garbe, Prof. Dr. University of Tuebingen, Department of dermatology

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00204607     History of Changes
Other Study ID Numbers: RNA-Mel-02
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 19, 2007
Last Verified: April 2007

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas