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5 patients, tetwtCEA DNA intradermal delivery with electroporation, not previously vaccinated with CEA66 DNA. Electrical pulses applied to vaccination sites in skin using Derma Vax immediately after DNA administration. One dose of Cyclophosphamide (300 mg/m2) will be given i.v. three days before each vaccination with tetwtCEA DNA.

10 patients, tetwtCEA DNA intradermal delivery with electroporation, previously vaccinated with CEA66 DNA.Electrical pulses applied to vaccination sites in skin using Derma Vax immediately after DNA administration.One dose of Cyclophosphamide (300 mg/m2) will be given i.v. three days before each vaccination with tetwtCEA DNA.

5 patients, tetwtCEA DNA intradermal delivery with electroporation + GM-CSF, not previously vaccinated with CEA66 DNA.Electrical pulses applied to vaccination sites in skin using Derma Vax immediately after DNA administration.One dose of Cyclophosphamide (300 mg/m2) will be given i.v. three days before each vaccination with tetwtCEA DNA.

Two vaccinations at week 0 and 12. Intradermal administration of 400ug DNA/dose with electroporation

tetwtCEA DNA (wt CEA with tetanus toxoid Th epitope)

Electrical pulses applied to vaccination sites in skin using Derma Vax immediately after DNA administration

Derma Vax (electroporation device)

GM-CSF will be given for 4 consecutive days starting the day before the vaccination as an intradermal/subcutaneous administration of 150 ug of GM-CSF

GM-CSF

One intravenous dose of 300 mg/m2 will be given three days before each vaccination with tetwtCEA DNA

Maria Liljefors, MD, PhD

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety Study of DNA Vaccine Delivered by Intradermal Electroporation to Treat Colorectal Cancer	NCT01064375	Colorectal Canc...	tetwtCEA DNA (w... Derma Vax (elec... GM-CSF Cyclophosphamid...	18 Years -	Karolinska University Hospital
Safety Study of DNA Vaccine Delivered by Intradermal Electroporation to Treat Colorectal Cancer	NCT01064375	Colorectal Canc...	tetwtCEA DNA (w... Derma Vax (elec... GM-CSF Cyclophosphamid...	18 Years -	Karolinska University Hospital

Spots Global Cancer Trial Database for tetwtcea dna (wt cea with tetanus toxoid th epitope)