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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

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

Inclusion Criteria:

- Histological 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

- Patients recruited from vaccination with CEA66 plasmid DNA must have completed trial
at 18 months if immune response is proven or proven to be non-immune responders in
two consecutive immunoassays.

- Age >18 years

- Karnofsky performance >80%

- Life expectancy of greater than 6 months

- Normal organ and marrow function

- Normal thyroid function as measured by serum T3, T4 and TSH

- Normal echocardiogram regarding arrhythmias (chronic or treated atrial fibrillation

- No concurrent treatment (chemotherapy or biological) may be planned during protocol

- Women or men of reproductive potential must agree to use adequate contraception prior
to study entry and for up to 3 months after the last injection

- Ability to understand and the willingness to sign an informed consent document

Exclusion Criteria:

- Immunotherapy or systemic corticosteroids within 8 weeks prior to entering the study

- Chemotherapy or radiotherapy within 2 months prior to entering the study

- Known hypersensitivity to GM-CSF

- Previous splenectomy or radiation therapy of the spleen

- Pregnancy or nursing

- HIV seropositivity

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic intracranial disease, congestive heart failure, unstable
angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that
would limit compliance with study requirements

- History of severe neurological, cardiovascular, renal, hepatic, respiratory, bone
marrow dysfunction, organ graft or autoimmune disease (treated or not)

- Concomitant medication with an anticoagulant (acetylsalicylic acid and low-molecular
weight heparin in prophylactic dose allowed)

- Other malignancy, except for the following: adequately treated basal cell or squamous
cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer
from which the patient is currently in complete remission, or any other cancer from
which the patient has been disease-free for 5 years

- 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)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety and immunogenicity of a DNA immunisation approach where tetwtCEA DNA will be administered in combination with electroporation.

Outcome Time Frame:

Within 72 weeks after immunisation

Safety Issue:


Principal Investigator

Maria Liljefors, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Oncology, Karolinska University Hospital/Institute


Sweden: Regional Ethical Review Board

Study ID:




Start Date:

December 2009

Completion Date:

September 2013

Related Keywords:

  • Colorectal Cancer
  • DNA vaccine
  • Electroporation
  • Colorectal Neoplasms