Intratumoral phIL12 GET (NCT05077033) | Clinical Trial Compass
CompletedPhase 1
Intratumoral phIL12 GET
Slovenia9 participantsStarted 2021-09-28
Plain-language summary
Electroporation provides non-viral gene delivery method for plasmid DNA. Its clinical application was already proven in preclinical and in clinical trial in treatment of melanoma skin metastases with plasmid coding IL-12, in USA. Intratumoral gene transfer of plasmid coding for IL-12 has proven safe end effective, having good local tumour control and some evidence indicates on abscopal effect. The EU directives recommend the use of plasmids without the gene for antibiotic resistance. For this purpose we constructed plasmid coding for IL-12 in accordance with the EU regulatory requirements.
In the proposed study we intend to study the safety and tolerability of the constructed plasmid, phIL12, in treatment of basal cell carcinomas in patients with operable tumors in head and neck region. The study is designed as exploratory, dose escalating with the aim to determine the dose of plasmid that produces IL-12 expression in the tumours with best biological activity, infiltration of the immune cells and no toxicity.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically or cytologically confirmed, previously untreated cutaneous basal cell carcinoma located in head and neck region.
* Solitary tumors, with largest diameter up to 3 cm, in the region where curative surgery is feasible.
* Age 18-years or older.
* Life expectancy \> 3 months.
* Physical performance in accordance with the Karnofsky scale ≥ 70 or \< 2 in accordance with World Health Organization (WHO) scale.
* The patient must be capable of understanding the treatment procedure and possible adverse events, which may arise during treatment.
* The patient must be capable of signing the informed consent to participate in the clinical study (voluntary and conscientious consent after education).
* Prior to inclusion in the trial, the patient must be presented at a multidisciplinary advisory team meeting.
Exclusion Criteria:
* Known malignancy elsewhere in/on the body.
* Lesions not suitable for treatment with GET (invasion into the bone, infiltration of large vessels).
* A life-threatening infection and/or severe heart failure and/or liver failure and/or other life-threatening systemic diseases.
* Significantly reduced lung function, which requires the determination of DLCO. Patients should not be treated if DLCO is abnormal.
* Treatment with immunosuppressive drugs, steroids and other drugs that would affect poor wound healing.
* Age under 18-years.
* Major disruptions in the coagulation system (who does not respond to the standard therapy - repla…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of acute adverse events
Timeframe: Adverse events 2 days after the treatment.
2
Number of adverse events 7 days after the treatment
Timeframe: Adverse events 7 days after the treatment.
3
Number of late adverse events
Timeframe: Adverse events 30 days after the treatment.
4
Evaluating quality of life with questionnaire one week after the treatment
Timeframe: Changes from baseline 7 days after the treatment.
5
Evaluating quality of life with questionnaire one month after the treatment
Timeframe: Changes from baseline 30 days after the treatment.