Induction of Specific Immune Responses Against Melanoma-Associated Antigens in Vivo by Intradermal Vaccination With Stabilized Tumor mRNA - a Clinical Phase I/II Trial
18 Years
75 Years
Both
Malignant Melanoma
Trial Information
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. 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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
toxicity
Principal Investigator
Claus Garbe, Prof. Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Tuebingen, Department of dermatology
Authority:
Germany: Ethics Commission
Study ID:
RNA-Mel-02
NCT ID:
NCT00204607
Start Date:
July 2004
Completion Date:
January 2007
Related Keywords:
- Malignant Melanoma
- Melanoma
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