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Colorectal CancerPhase 1/2El-porCEANCT01064375

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

A Phase 1/2 study testing tetwtCEA DNA (wt CEA with tetanus toxoid Th epitope), Derma Vax (electroporation device) and GM-CSF in people with Colorectal Cancer, run by Maria Liljefors at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
tetwtCEA DNA (wt CEA with tetanus toxoid Th epitope), Derma Vax (electroporation device) and GM-CSF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteSweden
Study dates
Dec 2009to Aug 2016
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%
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  • 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

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Department of Oncology, Karolinska University Hospital

    Stockholm, 171 76

Other trials in Sweden

About this study

Official title: 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.
Being tested
tetwtCEA DNA (wt CEA with tetanus toxoid Th epitope), Derma Vax (electroporation device), GM-CSF, Cyclophosphamide
Keywords
DNA vaccine, Electroporation
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tetwtCEA DNA (wt CEA with tetanus toxoid Th epitope)Biological

    Also called GM-CSF, cyclophosphamide

    Two vaccinations at week 0 and 12. Intradermal administration of 400ug DNA/dose with electroporation

  • Derma Vax (electroporation device)Device

    Also called GM-CSF, cyclophosphamide

    Electrical pulses applied to vaccination sites in skin using Derma Vax immediately after DNA administration

  • GM-CSFBiological

    Also called cyclophosphamide

    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

  • CyclophosphamideDrug

    Also called Sendoxan

    One intravenous dose of 300 mg/m2 will be given three days before each vaccination with tetwtCEA DNA

Study groups in NCT01064375
Study groupRoleWhat they receive
CEA DNA prime (cohort I)Experimental5 patients, tetwtCEA DNA intradermal delivery with electroporation, not previously vaccinated with CEA66 DNA. Electrical pulses applied to vaccination sites in skin using Derma Vax immediately after DNA administration. One dose of Cyclophosphamide (300 mg/m2) will be given i.v. three days before each vaccination with tetwtCEA DNA.
Receives: Biological: tetwtCEA DNA (wt CEA with tetanus toxoid Th epitope); Device: Derma Vax (electroporation device); Drug: Cyclophosphamide
CEA DNA boost (cohort II)Experimental10 patients, tetwtCEA DNA intradermal delivery with electroporation, previously vaccinated with CEA66 DNA.Electrical pulses applied to vaccination sites in skin using Derma Vax immediately after DNA administration.One dose of Cyclophosphamide (300 mg/m2) will be given i.v. three days before each vaccination with tetwtCEA DNA.
Receives: Biological: tetwtCEA DNA (wt CEA with tetanus toxoid Th epitope); Device: Derma Vax (electroporation device); Drug: Cyclophosphamide
CEA DNA prime + GM-CSF (cohort III)Experimental5 patients, tetwtCEA DNA intradermal delivery with electroporation + GM-CSF, not previously vaccinated with CEA66 DNA.Electrical pulses applied to vaccination sites in skin using Derma Vax immediately after DNA administration.One dose of Cyclophosphamide (300 mg/m2) will be given i.v. three days before each vaccination with tetwtCEA DNA.
Receives: Biological: tetwtCEA DNA (wt CEA with tetanus toxoid Th epitope); Device: Derma Vax (electroporation device); Biological: GM-CSF; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Within 72 weeks after immunisation

Secondary outcomes (2)

  1. 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

    Measured: Within 72 weeks after immunisation

  2. To compare effects (safety and immunogenicity) of additional adjuvance with GM-CSF

    Measured: Within 72 weeks after immunsation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2010 (estimated)
  2. Study startDec 2009
  3. Primary completionMar 2012
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01064375
Sponsor's protocol ID
El-porCEA
Other IDs
2009-009863-75, 2009
Acronym
El-porCEA
Status last verified
Aug 2022
First submitted
5 Feb 2010
Last updated
19 Aug 2022
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing tetwtCEA DNA (wt CEA with tetanus toxoid Th epitope), Derma Vax (electroporation device) and GM-CSF in people with Colorectal Cancer, run by Maria Liljefors at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01064375.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.

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