Calcium electroporation for recurrent head and neck cancer: A clinical phase I study

Abstract

Background Calcium electroporation is a novel cancer treatment, which combines temporary cell permeability from electroporation with a high influx of calcium intracellularly resulting in cancer cell necrosis. Methods A phase I trial performing calcium electroporation on 6 patients suffering from recurrent head and neck cancer. In general anesthesia, intratumoral calcium injections were followed by electroporation. Safety was monitored by adverse events registration, serum Ca 2+ , ECG, and pain scores. Tumor response was measured on PET/MRI scans. Results Procedures were performed without complications. No serious adverse events, signs of hypercalcemia, or cardiac arrhythmias were observed. Two months post‐treatment tumor responses on MRI: three partial responses, one stable disease, and two progression. Responses on PET: one partial metabolic disease, four with stable metabolic disease, and one not evaluable. One patient was without clinical evidence of disease after 12 months of observation. Conclusion Calcium electroporation is feasible and safe in head and neck tumors. Clinical responses were observed in three of six patients, warranting further studies. Level of Evidence Level 4

Evaluation of Calcium Electroporation for the Treatment of Cutaneous Metastases: A Double Blinded Randomised Controlled Phase II Trial

“…Preclinical studies provided the first support for the efficacy across cancer histologies, as well as an explanation of the mechanisms of action [11,13,14,[20][21][22][23][24][25][26][27]. The results of the first clinical trials suggested that Ca-EP is safe and efficient at the local level for tumours of different types, including cutaneous metastases from breast cancer and malignant melanoma and recurrent head and neck cancer [11,20]. Moreover, a case report showed that Ca-EP is able to initiate a systemic immune response and target untreated metastases in a patient suffering from malignant melanoma [28].…”

A Comprehensive Review of Calcium Electroporation—A Novel Cancer Treatment Modality

“…After the first clinical trial using calcium electroporation, several studies commenced ( Table 2). A phase I study treating recurrent mucosal head and neck cancer patients with calcium electroporation has recently been published [120]. Six patients that were previously irradiated, deemed inoperable, and without further treatment options, were included in the trial testing safety of the treatment on larger mucosal head and neck cancers.…”

“…Initial clinical studies have used a high dose of calcium (220-225 mM in a volume equivalent to 50% of the tumor volume) but data also points to lower doses of calcium being effective [61,116]. This needs to be further investigated; nonetheless, for a safety point of view high doses of calcium were well tolerated [19,120].…”

Calcium Electroporation of Equine Sarcoids

“…Calcium electroporation is a prospective novel anticancer treatment, showing promising response rates in preclinical and clinical trials [3][4][5][6][7]. High calcium concentrations are introduced to the cell cytosol by electroporation, a method where short, high-voltage pulses permeabilize the cell membrane, allowing for passage of non-permeant ions and molecules, e.g., calcium [4,7].…”