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Sponsored by: |
Cytos Biotechnology AG |
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Information provided by: | Cytos Biotechnology AG |
ClinicalTrials.gov Identifier: | NCT00306514 |
The purpose of this study is to evaluate whether vaccination with a Melan-A VLP vaccine leads to a specific cellular immune response in patients with malignant melanoma at advanced stage of the disease.
Condition | Intervention | Phase |
---|---|---|
Melanoma |
Biological: CYT004-MelQbG10 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Uncontrolled, Parallel Assignment |
Official Title: | A Phase IIa Study to Evaluate Safety, Tolerability, and Immunogenicity of a Melan-A VLP Vaccine in HLA-A2 Positive Patients With Stage III/IV Malignant Melanoma |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Dept. of Dermatology, Venerology and Allergy | |
Berlin, Germany, 10117 |
Principal Investigator: | Wolfram Sterry, MD | University Hospital Charite, Berlin, D |
Study ID Numbers: | CYT004-MelQbG10 01 |
Study First Received: | March 23, 2006 |
Last Updated: | September 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00306514 History of Changes |
Health Authority: | Germany: Paul-Ehrlich-Institut |
metastatic malignant melanoma of the skin |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Melanoma, Familial Neuroendocrine Tumors Melanoma |
Neuroectodermal Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Nevi and Melanomas Neuroendocrine Tumors Melanoma |