Vaccination With Tumor mRNA in Metastatic Melanoma - Fixed Combination Versus Individual Selection of Targeted Antigens
- Conditions
- Malignant Melanoma
- Interventions
- Biological: mRNA coding for melanoma associated antigens
- Registration Number
- NCT00204516
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
- malignant melanoma stage III/IV
- fresh frozen tumor tissue available
- informed consent given
- Karnofsky >= 70%
- brain metastasis
- parallel chemotherapy
- systemic treatment with glucocorticoids
- other malignancies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description mRNA Vacc mRNA coding for melanoma associated antigens - mRNA Vacc GM-CSF -
- Primary Outcome Measures
Name Time Method Tolerability every 4 weeks Side effects will be monitored using CTCAE criteria. Tolerability and toxicity profiles will be calculated.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Dermatology, University of Tuebingen
🇩🇪Tuebingen, Germany