drugset / Trial / NCT03051269
Calcium Electroporation for Head and Neck Cancer
NaSingle-groupOpen-labelTreatment
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).
Timeline
- Start
- 2016-05
- Primary completion
- 2018-12
- Completion
- 2019-02
Publications
- Background 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.
- Background Hansen 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.
- Background Frandsen 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.
- Background Plaschke 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Calcium Chloride | Unknown | 9 mg/ml | Other |