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

This study has been completed.
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00204607
First received: September 13, 2005
Last updated: April 18, 2007
Last verified: April 2007

September 13, 2005
April 18, 2007
July 2004
Not Provided
  • toxicity
  • immune response
Same as current
Complete list of historical versions of study NCT00204607 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Intradermal Vaccination With Stabilized Tumor mRNA - a Clinical Phase I/II Trial in Melanoma Patients
Induction of Specific Immune Responses Against Melanoma-Associated Antigens in Vivo by Intradermal Vaccination With Stabilized Tumor mRNA - a Clinical Phase I/II Trial

vaccination protocol to induce specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigen

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Melanoma
  • Biological: mRNA
  • Drug: GM-CSF s.c.
Not Provided
Weide B, Pascolo S, Scheel B, Derhovanessian E, Pflugfelder A, Eigentler TK, Pawelec G, Hoerr I, Rammensee HG, Garbe C. Direct injection of protamine-protected mRNA: results of a phase 1/2 vaccination trial in metastatic melanoma patients. J Immunother. 2009 Jun;32(5):498-507.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
January 2007
Not Provided

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00204607
RNA-Mel-02
Not Provided
Not Provided
University Hospital Tuebingen
Not Provided
Principal Investigator: Claus Garbe, Prof. Dr. University of Tuebingen, Department of dermatology
University Hospital Tuebingen
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP