Safety Study of DNA Vaccine Delivered by Intradermal Electroporation to Treat Colorectal Cancer
El-porCEA
Assessment of Safety and Immunogenicity of Intradermal Electroporation of tetwtCEA DNA in Patients With Colorectal Cancer
2 other identifiers
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 colorectal-cancer
Started Dec 2009
Longer than P75 for phase_1 colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 5, 2010
CompletedFirst Posted
Study publicly available on registry
February 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedAugust 19, 2022
August 1, 2022
2.2 years
February 5, 2010
August 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the safety and immunogenicity of a DNA immunisation approach where tetwtCEA DNA will be administered in combination with electroporation.
Within 72 weeks after immunisation
Secondary Outcomes (2)
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
Within 72 weeks after immunisation
To compare effects (safety and immunogenicity) of additional adjuvance with GM-CSF
Within 72 weeks after immunsation
Study Arms (3)
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.
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.
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.
Interventions
Two vaccinations at week 0 and 12. Intradermal administration of 400ug DNA/dose with electroporation
Electrical pulses applied to vaccination sites in skin using Derma Vax immediately after DNA administration
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
One intravenous dose of 300 mg/m2 will be given three days before each vaccination with tetwtCEA DNA
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maria Liljeforslead
- Karolinska Institutetcollaborator
- Swedish Institute for Infectious Disease Controlcollaborator
- Cyto Pulse Sciences, Inc.collaborator
Study Sites (1)
Department of Oncology, Karolinska University Hospital
Stockholm, 171 76, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Liljefors, MD, PhD
Department of Oncology, Karolinska University Hospital/Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, senior consultant
Study Record Dates
First Submitted
February 5, 2010
First Posted
February 8, 2010
Study Start
December 1, 2009
Primary Completion
March 1, 2012
Study Completion
August 1, 2016
Last Updated
August 19, 2022
Record last verified: 2022-08