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Safety Study of DNA Vaccine Delivered by Intradermal Electroporation to Treat Colorectal Cancer (El-porCEA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Karolinska University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Karolinska Institutet
Swedish Institute for Infectious Disease Control
Cyto Pulse Sciences, Inc.
Information provided by (Responsible Party):
Maria Liljefors, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01064375
First received: February 5, 2010
Last updated: February 27, 2012
Last verified: February 2012

February 5, 2010
February 27, 2012
December 2009
January 2013   (final data collection date for primary outcome measure)
To evaluate the safety and immunogenicity of a DNA immunisation approach where tetwtCEA DNA will be administered in combination with electroporation. [ Time Frame: Within 72 weeks after immunisation ] [ Designated as safety issue: Yes ]
To evaluate the safety and immunogenicity of a DNA immunisation approach where tetwtCEA DNA will be administered in combination with electroporation [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01064375 on ClinicalTrials.gov Archive Site
  • 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 [ Time Frame: Within 72 weeks after immunisation ] [ Designated as safety issue: No ]
  • To compare effects (safety and immunogenicity) of additional adjuvance with GM-CSF [ Time Frame: Within 72 weeks after immunsation ] [ Designated as safety issue: Yes ]
  • To assess the efficiency of priming immunological responses to CEA by intradermal administration of tetwtCEA DNA in combination with electroporation [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • To compare effects (safety and immunogenicity) of additional adjuvance with GM-CSF [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • 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
    Other Names:
    • GM-CSF
    • cyclophosphamide
  • Device: Derma Vax (electroporation device)
    Electrical pulses applied to vaccination sites in skin using Derma Vax immediately after DNA administration
    Other Names:
    • GM-CSF
    • cyclophosphamide
  • 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
    Other Names:
    • GM-CSF
    • cyclophosphamide
  • Drug: Cyclophosphamide
    One intravenous dose of 300 mg/m2 will be given three days before each vaccination with tetwtCEA DNA
    Other Name: Sendoxan
  • Experimental: CEA DNA prime (cohort I)
    5 patients, tetwtCEA DNA intradermal delivery with electroporation, not previously vaccinated with CEA66 DNA
    Interventions:
    • Biological: tetwtCEA DNA (wt CEA with tetanus toxoid Th epitope)
    • Device: Derma Vax (electroporation device)
    • Drug: Cyclophosphamide
  • Experimental: CEA DNA boost (cohort II)
    10 patients, tetwtCEA DNA intradermal delivery with electroporation, previously vaccinated with CEA66 DNA
    Interventions:
    • Biological: tetwtCEA DNA (wt CEA with tetanus toxoid Th epitope)
    • Device: Derma Vax (electroporation device)
    • Drug: Cyclophosphamide
  • Experimental: CEA DNA prime + GM-CSF (cohort III)
    5 patients, tetwtCEA DNA intradermal delivery with electroporation + GM-CSF, not previously vaccinated with CEA66 DNA
    Interventions:
    • Biological: tetwtCEA DNA (wt CEA with tetanus toxoid Th epitope)
    • Device: Derma Vax (electroporation device)
    • Biological: GM-CSF
    • Drug: Cyclophosphamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
September 2013
January 2013   (final data collection date for primary outcome measure)

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 allowed)
  • No concurrent treatment (chemotherapy or biological) may be planned during protocol treatment
  • 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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01064375
El-porCEA, 2009-009863-75
Yes
Maria Liljefors, Karolinska University Hospital
Maria Liljefors
  • Karolinska Institutet
  • Swedish Institute for Infectious Disease Control
  • Cyto Pulse Sciences, Inc.
Principal Investigator: Maria Liljefors, MD, PhD Department of Oncology, Karolinska University Hospital/Institute
Karolinska University Hospital
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP