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Clinical Trial: Vaccination with Tumor mRNA in Metastatic Melanoma - Fixed Combination Versus Individual Selection of Targeted Antigens
This study is not yet open for patient recruitment.
Verified by University Hospital Tuebingen February 2005
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Purpose
vaccination protocol to induce specific immune responses against melanoma associated antigens by intradermal injections of mRNA coding for the corresponding antigen
| Condition | Intervention | Phase |
|---|---|---|
| Malignant Melanoma | Vaccine: mRNA coding for melanoma associated antigens Drug: GM-CSF | Phase I Phase II |
MedlinePlus related topics: Melanoma
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Pilot Study of Intradermal Vaccination of Melanoma Patients with a Fixed Combination of mRNAs Compared to an Individulized Selection After Analysis of Antigen Expression in Tumor Tissue
Further Study Details:
Primary Outcomes: toxicity; immune responses
Expected Total Enrollment: 30
Expected Total Enrollment: 30
Study start: January 2006; Expected completion: December 2008
Last follow-up: December 2008; Data entry closure: December 2008
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 individulized selection of mRNAs after analysis of overexpressed melanoma antigens in autologous tumor tissue. GM-CSF is used as an adjuvans. Phase I/II clinical trial to analyse safety and immune respones in stage III/IV melanoma patients.
Eligibility
Ages Eligible for Study: 18 Years - 80 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- malignant melanoma stage III/IV
- fresh frozen tumor tissue available
- informed consent given
- Karnofsky >= 70%
Exclusion Criteria:
- brain metastasis
- parallel chemotherapy
- systemic treatment with glucocorticoids
- other malignacies
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00204516
Claus Garbe, Prof. Dr. 07071/2985748
Germany
Department of Dermatology, University of Tuebingen, Tuebingen, 72076, Germany
Claus Garbe, Prof. Dr. 07071/2985748
Claus Garbe, Prof. Dr., Principal Investigator
Claus Garbe, Prof. Dr., Principal Investigator
Study chairs or principal investigators
Claus Garbe, Prof. Dr., Principal Investigator, University of Tuebingen, Department of Dermatology
More Information
Study ID Numbers: RNA-Mel-03
Last Updated: September 19, 2005
Record first received: September 13, 2005
ClinicalTrials.gov Identifier: NCT00204516
Health Authority: Germany: Ethics Commission
ClinicalTrials.gov processed this record on 2005-09-20
Last Updated: September 19, 2005
Record first received: September 13, 2005
ClinicalTrials.gov Identifier: NCT00204516
Health Authority: Germany: Ethics Commission
ClinicalTrials.gov processed this record on 2005-09-20
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