Intradermal Vaccination With Stabilized Tumor mRNA - a Clinical Phase I/II Trial in Melanoma Patients
Phase 1
Completed
- Conditions
- Malignant Melanoma
- Registration Number
- NCT00204607
- Lead Sponsor
- 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method toxicity immune response
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Dermatology, University of Tübingen
🇩🇪Tübingen, Germany