NCT01064375

Safety Study of DNA Vaccine Delivered by Intradermal Electroporation to Treat Colorectal Cancer

Assessment of Safety and Immunogenicity of Intradermal Electroporation of tetwtCEA DNA in Patients With Colorectal Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Maria Liljefors · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	tetwtCEA DNA (wt CEA with tetanus toxoid Th epitope)	Two vaccinations at week 0 and 12. Intradermal administration of 400ug DNA/dose with electroporation
DEVICE	Derma Vax (electroporation device)	Electrical pulses applied to vaccination sites in skin using Derma Vax immediately after DNA administration
BIOLOGICAL	GM-CSF	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
DRUG	Cyclophosphamide	One intravenous dose of 300 mg/m2 will be given three days before each vaccination with tetwtCEA DNA

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-03-01
• Completion: 2016-08-01
• First posted: 2010-02-08
• Last updated: 2022-08-19

Locations

1 site across 1 country: Sweden