Spots Global Cancer Trial Database for Safety Study of DNA Vaccine Delivered by Intradermal Electroporation to Treat Colorectal Cancer
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Trial Identification
Brief Title: Safety Study of DNA Vaccine Delivered by Intradermal Electroporation to Treat Colorectal Cancer
Official Title: Assessment of Safety and Immunogenicity of Intradermal Electroporation of tetwtCEA DNA in Patients With Colorectal Cancer
Study ID: NCT01064375
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate the safety and immunogenicity of a CEA DNA immunisation approach in patients with colorectal cancer. The DNA plasmid, tetwtCEA, encodes wild type human CEA fused to a tetanus toxoid T helper epitope. The vaccine will be delivered using an intradermal electroporation device, Derma Vax (Cyto Pulse Sciences). The following will be assessed: * The efficiency of priming immunological responses to CEA by intradermal administration of CEA DNA in combination with electroporation. * The efficiency of boosting immunological responses to CEA by intradermal administration of CEA DNA in combination with electroporation in subjects already vaccinated with CEA DNA. * GM-CSF will be administered to half of the subjects primed with CEA DNA in combination with electroporation and any possible adjuvant effects of GM-CSF will be evaluated.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Department of Oncology, Karolinska University Hospital, Stockholm, , Sweden
Contact Details
Name: Maria Liljefors, MD, PhD
Affiliation: Department of Oncology, Karolinska University Hospital/Institute
Role: PRINCIPAL_INVESTIGATOR
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