El-porCEA: Assessment of safety and immunogenicity of intradermal electroporation of tetwtCEA DNA in patients with colorectal cancer.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-009863-75-SE

Enrollment

Registered

2009-06-24

Start date

2009-08-26

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal carcinoma MedDRA version: 9.1 Level: LLT Classification code 10010036 Term: Colorectal carcinoma

Interventions

Product Name: tetwtCEA DNA Product Code: tetwtCEA DNA Pharmaceutical Form: Solution for injection INN or Proposed INN: pKCMV-tetwtCEA Other descriptive name: tetwtCEA plasmid Concentration unit: mg/ml

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Histologically confirmed AJCC stage II or III colorectal cancer - Resection of the primary tumour without evidence of remaining macroscopic disease - Allowable standard chemotherapy or radiotherapy in AJCC stage III completed minimum 2 months prior study entry - Karnofsky performance >80 % - Normal organ and marrow function In addition, up to 10 patients should have completed the immunisations from our previous study “CEA DNA vaccination in colorectal cancer” EudraCT 2005-006015-44 and completed the followuptime i.e 18 months. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Immunotherapy or systemic corticosteroids within 8 weeks, chemotherapy or radiotherapy within 2 months prior to entering the study - Uncontrolled intercurrent illness or history of severe organ dysfunction or other malignancy - Cardiac demand pacemakers or surgically implanted defibrillators - Patients that has any metal implants in the area of the injection, (e.g. shoulder implant in the upper arm or shoulder girdle)

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the safety and immunogenicity of a DNA immunisation approach where tetwtCEA DNA will be administered in combination with electroporation;Secondary Objective: - To assess the efficiency of priming immunological responses to CEA by intradermal administration of tetwtCEA DNA in combination with electroporation - To assess the efficiency of boosting immunological responses to CEA by intradermal administration of tetwtCEA DNA in combination with electroporation in subjects already vaccinated with CEA DNA - To evaluate tumour recurrence and patient survival in relation to vaccine-induced immune responses. - To compare effects of additional adjuvans with GM-CSF.;Primary end point(s): -The primary end point is to determine safety and immunogenicity of delivery of tetwtCEA DNA vaccine in combination with electroporation.	—

Measure

Time frame

Main Objective: To evaluate the safety and immunogenicity of a DNA immunisation approach where tetwtCEA DNA will be administered in combination with electroporation;Secondary Objective: - To assess the efficiency of priming immunological responses to CEA by intradermal administration of tetwtCEA DNA in combination with electroporation - To assess the efficiency of boosting immunological responses to CEA by intradermal administration of tetwtCEA DNA in combination with electroporation in subjects already vaccinated with CEA DNA - To evaluate tumour recurrence and patient survival in relation to vaccine-induced immune responses. - To compare effects of additional adjuvans with GM-CSF.;Primary end point(s): -The primary end point is to determine safety and immunogenicity of delivery of tetwtCEA DNA vaccine in combination with electroporation.

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Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026