Calcium Electroporation for Head and Neck Cancer
1 other identifier
interventional
6
1 country
1
Brief Summary
In a phase I protocol to primarily investigate the safety of using calcium combined with electroporation on recurrent head and neck cancers. Secondly, to evaluate tumour response on PET/MRI (positron emission tomography/magnetic resonance imaging), clinical evaluation, biopsies. Thirdly, to evaluate the effect of calcium electroporation compared to electrochemotherapy as well as the patients life-of-quality through questionnaires, EORTC QLQ C-30 and H\&N35 (european organisation for research and treatment of cancer).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2016
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 17, 2017
CompletedFirst Posted
Study publicly available on registry
February 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedFebruary 13, 2017
February 1, 2017
2.6 years
January 17, 2017
February 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Treatment-Emergent Adverse Events [Safety and Tolerability]
Evaluated by change in CTCAE (common terminology criteria for adverse events) at different timepoints.
CTCAE are evaluated at several timepoints: 1) Baseline (before treatment). 2) 30 minutes and 6 hours after treatment. 3) Once at day 1, 2 and 3 after treatment. 4) 1 week after treatment. 5) 2 weeks after treatment. 6) 1 and 2 months after treatment.
Change in Treatment-Emergent Adverse Events [Safety and Tolerability]
Evaluated by change in calcium levels in blood samples at different time points.
Blood samples evaluating calcium levels are taken at 1) Baseline. 2) 30 min after treatment. 3) 6 hours after treatment. 4) At day 1, 2, and 3 after treatment.
Secondary Outcomes (4)
Tumour response
PET/MRI are performed at baseline and evaluated again at 1 and 2 months after treatment.
Tumour response
Clinical evaluation is performed daily in the first 3 days post-treatment, again at week 1 and 2, and 1 and 2 months post-treatment.
Tumour response
Biopsies are performed at baseline and again at 1 and 2 months after treatment.
Comparing calcium electroporation to electrochemotherapy
1 year
Study Arms (1)
calcium chloride
EXPERIMENTALOnly one arm. All 6 enrolled patients are treated with calcium electroporation.
Interventions
Tumour site is injected with a solution of 9 mg/ml calcium chloride and afterwards the tumour site is given electroporation to facilitate calcium to enter the cell cytosol.
Performed by single use electrodes attaches to a device called "Cliniporator" provided from IGEA, ITALY.
Eligibility Criteria
You may qualify if:
- Subject age \> 18 years.
- Verified cancer in the head and neck region of any histology.
- At least one tumour lesion should be accessible for electroporation.
- Performance status WHO \<= 2.
- Progressive and/or metastatic disease.
- Expected survival of \> 3 months.
- A treatment-free interval of more than 4 weeks since chemotherapy or radiation therapy of the treatment area.
- The subject should have been offered the current standard treatment. If there is no further standard treatment to offer or if the subject does not want to receive the treatments offered, the subject may be included in the trial.
- The subject should be able to understand the information for participants and be willing and able to comply with hospitalization and the agreed follow-up visits and tests.
- Platelets ≥ 50 billion/L, INR(international normalized ratio)\> 1.5. Medical correction is allowed, e.g. correction of a high INR using vitamin K.
- Sexually active men and women who can become pregnant must use adequate contraception during this trial (pill, spiral, injection of prolonged progestin, subdermal implantation, hormone-containing vaginal devices, transdermal patches).
- Signed informed consent.
You may not qualify if:
- Patients should be excluded if they meet just one of the criteria stated below:
- Symptomatic progression of the subject's cancer disease that requires another intervention.
- Allergy to constituents of the planned anesthesia.
- Coagulation disorder that cannot be corrected.
- Chronic renal dysfunction with creatinine\> 200 mmol/L will trigger a Cr-51-EDTA (Ethylenediaminetetraacetic acid) clearance.
- Pregnancy or lactation.
- If participating in other clinical trials involving experimental drugs or involved in a trial within 4 weeks prior to study drug administration.
- Other disorders investigator finds incompatible with participation in the trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigshospitalet, Denmarklead
- Herlev Hospitalcollaborator
Study Sites (1)
Department of Otorhinolaryngology, Rigshospitalet, Copenhagen University Hospital
Copenhagen, 2100, Denmark
Related Publications (4)
Frandsen SK, Gibot L, Madi M, Gehl J, Rols MP. Calcium Electroporation: Evidence for Differential Effects in Normal and Malignant Cell Lines, Evaluated in a 3D Spheroid Model. PLoS One. 2015 Dec 3;10(12):e0144028. doi: 10.1371/journal.pone.0144028. eCollection 2015.
PMID: 26633834BACKGROUNDHansen EL, Sozer EB, Romeo S, Frandsen SK, Vernier PT, Gehl J. Dose-dependent ATP depletion and cancer cell death following calcium electroporation, relative effect of calcium concentration and electric field strength. PLoS One. 2015 Apr 8;10(4):e0122973. doi: 10.1371/journal.pone.0122973. eCollection 2015.
PMID: 25853661BACKGROUNDFrandsen SK, Gissel H, Hojman P, Tramm T, Eriksen J, Gehl J. Direct therapeutic applications of calcium electroporation to effectively induce tumor necrosis. Cancer Res. 2012 Mar 15;72(6):1336-41. doi: 10.1158/0008-5472.CAN-11-3782. Epub 2012 Jan 26.
PMID: 22282658BACKGROUNDPlaschke CC, Gothelf A, Gehl J, Wessel I. Electrochemotherapy of mucosal head and neck tumors: a systematic review. Acta Oncol. 2016 Nov;55(11):1266-1272. doi: 10.1080/0284186X.2016.1207803. Epub 2016 Oct 5.
PMID: 27705053BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Irene Wessel
Rigshospitalet, Dept. of Head and Neck Surgery, Copenhagen, Denmark
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant
Study Record Dates
First Submitted
January 17, 2017
First Posted
February 13, 2017
Study Start
May 1, 2016
Primary Completion
December 1, 2018
Study Completion
February 1, 2019
Last Updated
February 13, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share