None listed
Conditions
Brief summary
The purpose of this study is to determine whether a new treatment, called Targeted Osmotic Lysis (TOL), is a safe and tolerable treatment for patients with well-differentiated cutaneous squamous cell carcinoma, a specific type of skin cancer. Who is it for? You may be eligible for this study if you are an adult between the ages of 40-75 who has been diagnosed with well-differentiated cutaneous squamous cell carcinoma on the head, neck, mid-upper anterior chest or arms. Study details All participants in this study will be asked to take digoxin, a well established medication, and attend sessions every 6 days for 3 weeks to receive TOL treatment. TOL treatment will include laying in the CPEFG unit for 2 hours each treatment, while also taking a daily dose of digoxin orally during the active treatment period. During each session, participants will be monitored via ECG and using photographs, as well as for any side effects that may occur. Participants will also be followed up for 30 days after the final session for any additional side effects, to monitor their cancer and complete questionnaires. It is hoped that this research will help determine if TOL is a safe and effective treatment option for those who have been diagnosed with diagnosed with well-differentiated cutaneous squamous cell carcinoma.
Interventions
The new treatment is the Targeted Osmotic Lysis system (TOL) which combines a common heart medication (called Digoxin) with electrical pulses (PEF Stimulation) from a new Coaxial Pulsed Electrical Field Generator (CPEFG) at the same time. The CPEFG is a new device that pulses a low voltage electric field and targets cancer cells. This study is testing the TOL system which includes digoxin. Digoxin is an older, well-established medication used in Australia for certain cardiac conditions, but it i
The new treatment is the Targeted Osmotic Lysis system (TOL) which combines a common heart medication (called Digoxin) with electrical pulses (PEF Stimulation) from a new Coaxial Pulsed Electrical Field Generator (CPEFG) at the same time. The CPEFG is a new device that pulses a low voltage electric field and targets cancer cells. This study is testing the TOL system which includes digoxin. Digoxin is an older, well-established medication used in Australia for certain cardiac conditions, but it is not approved for the treatment of CSCC. Participants will be required to take an oral tablet dose of between 0.125 – 0.5mg daily. Digoxin dosing will be individualised based on the participant's age, weight, and renal function. The CPEFG, in conjunction with Digoxin forms the TOL system. The CPEFG device uses a set of circular rings placed around the body to create a gentle, low-voltage electrical field while the participant lies comfortably on a table. The electrical field (using a low voltage of 18 volts) is carefully controlled to be even and consistent in the area being treated. The intervention will be administered by a dermatologist. The study consists of 3 phases: 1. Pre-treatment Period: (up to 14 days before the TOL treatment starts) 2. Active treatment Period: (6 in person visits and 3 phone calls, over a period of 3 weeks) 3. Post-Treatment Follow-Up Period (5 in person visits, for up to 12 months) During the active treatment period, participants will have three (3) cycles of treatment, each treatment cycle consisting of two (2) hours on two (2) consecutive days, over three (3) weeks There will be six (6) days between cycles. For example, from completion of day two (2) in cycle one (1), there are six (6) days until commencement of day one (1) in cycle 2. During each Treatment Day, vital signs, ECGs, and treatment photographs will be performed, along with two (2) hours of electrical pulses from the CPFEG device. Each treatment day visit will take approximately 3 hours.
Sponsors
Oleander Medical Australia Pty. Ltd.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age range 40-75 years old 2. Confirmed diagnosis of well-differentiated cutaneous squamous cell carcinoma (CSCC) on the chest, back, legs, arms and abdomen, with lesion(s) <2cm in diameter. 3. Confirmed VGSC overexpression of the target lesion. 4. Participants must be sufficiently mobile to be able to move themselves in and out of the CPEFG with minimal assistance. 5. The participant is willing and able to provide informed consent 6. The participant must be willing and able to comply with the requirements of the protocol and follow directions from the clinic staff.
Exclusion criteria
1. Acute intercurrent illness or unstable clinical condition as determined by the treating physician or medical monitor. 2. Major surgery requiring general anesthesia within 12 weeks. 3. Second malignancy other than non-melanoma skin cancer within the preceding 5 years. 4. Weight greater than or equal to 136 kg. 5. Participants with recurrent cutaneous squamous cell carcinoma 6. Participants with metal implants 7. Participants with documented heart failure 8. Clinically significant hepatic, renal, or cardiac dysfunction, including: a. Total bilirubin >1.5mg/dL or AST/ALT >2.5 x ULN b. Creatinine clearance (CrCl < 30ml/ min c. LVEF 3.0 or hemopoietic suppression, hemoglobin < 8 g/dl. 9. Clinically significant abnormality of coagulation, international normalized ratio (INR) level >3.0 or hemopoietic suppression, hemoglobin < 8 g/dl. 10. Abnormal ECG including: a. bradycardia 450msec c. AV block grade II or higher d. Interventricular conduction delay with a QRS over 120 msec. 11. Cardiovascular conditions that contraindicate use of cardiac glycosides (e.g. atrial fibrillation, ventricular tachycardia, ventricular fibrillation, IHSS, sick sinus syndrome, AV block, restrictive cardiomyopathy, cor pulmonale, constrictive pericarditis, hypokalemia, renal impairment, and thyroid disease). 12. Central nervous system tumour or metastasis. 13. Participants who are immunosuppressed or immunodeficient 14. Pregnant or lactating. 15. Participants of childbearing potential who are unwilling or unable to use highly effective contraception (e.g. intra-uterine device, bilateral tubal ligation, vasectomized partner). 16. Participated in another clinical investigation within 3 months. 17. Participants that are on sodium channel blocking agents, (e.g., tricyclic anti-depressants, anti-epileptic agents, Class I anti-arrhythmic, or the anti-anginal agent ranolazine within 4 weeks of the first TOL treatment. 18. Current use of drugs with significant drug-drug interaction with digoxin or allopurinol. 19. Intolerance of, contra-indicated or allergic to digoxin or allopurinol. 20. Those who, in the judgement of the treating physician, investigator, or study monitor have any clinically significant ongoing medical condition (excluding the participant’s cancer), e.g., discovery of a previously unidentified adverse reaction to the cardiac glycoside, that might jeopardize the participant’s safety or interfere with the absorption, distribution, metabolism or excretion of the digoxin.
Outcome results
None listed