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

NCT01064375 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-08-19

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER

  • Swedish Institute for Infectious Disease Control

    collaborator OTHER

  • Cyto Pulse Sciences, Inc.

    collaborator INDUSTRY

  • Maria Liljefors

    lead OTHER

Principal Investigators

  • Maria Liljefors, MD, PhD · Department of Oncology, Karolinska University Hospital/Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-03-31
Completion
2016-08-31

Countries

  • Sweden

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01064375 on ClinicalTrials.gov