Back to results

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

Primary Purpose

Colorectal Cancer

Status

Completed

Phase

Phase 1

Locations

Sweden

Study Type

Interventional

Intervention

tetwtCEA DNA (wt CEA with tetanus toxoid Th epitope)

Derma Vax (electroporation device)

GM-CSF

Cyclophosphamide

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring DNA vaccine, Electroporation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Department of Oncology, Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

CEA DNA prime (cohort I)

CEA DNA boost (cohort II)

CEA DNA prime + GM-CSF (cohort III)

Arm Description

5 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.

10 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.

5 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01064375

First Posted

February 5, 2010

Last Updated

August 18, 2022

Sponsor

Maria Liljefors

Collaborators

Karolinska Institutet, Swedish Institute for Infectious Disease Control, Cyto Pulse Sciences, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01064375

Brief Title

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

Acronym

El-porCEA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Maria Liljefors

Collaborators

Karolinska Institutet, Swedish Institute for Infectious Disease Control, Cyto Pulse Sciences, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

DNA vaccine, Electroporation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CEA DNA prime (cohort I)

Arm Type

Experimental

Arm Description

Arm Title

CEA DNA boost (cohort II)

Arm Type

Experimental

Arm Description

Arm Title

CEA DNA prime + GM-CSF (cohort III)

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

tetwtCEA DNA (wt CEA with tetanus toxoid Th epitope)

Other Intervention Name(s)

GM-CSF, cyclophosphamide

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Derma Vax (electroporation device)

Other Intervention Name(s)

GM-CSF, cyclophosphamide

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

GM-CSF

Other Intervention Name(s)

cyclophosphamide

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Other Intervention Name(s)

Sendoxan

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

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

Time Frame

Within 72 weeks after immunsation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria Liljefors, MD, PhD

Organizational Affiliation

Department of Oncology, Karolinska University Hospital/Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Oncology, Karolinska University Hospital

City

Stockholm

ZIP/Postal Code

171 76

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs