Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
9 participants
INTERVENTIONAL
2021-09-28
2023-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intratumoral phIL12 gene electrotransfer
phIL12 GET
intratumoral phIL12 gene electrotransfer
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
phIL12 GET
intratumoral phIL12 gene electrotransfer
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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 - replacement of vitamin K or freshly frozen plasma).
* A chronic decline in the kidney function (creatinine \> 150 µmol/L).
* Epilepsy.
* Pregnancy and breast-feeding.
* The patient's incapability of comprehending the purpose or course of the trial, or not agreeing to be included in the trial.
* Patients unwilling or unable to comply with the protocol requirements and scheduled visits.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institute of Oncology Ljubljana
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institute of Oncology Ljubljana
Ljubljana, , Slovenia
University Medical Centre Ljubljana, Department of Otorhinolaryngology and Cervicofacial Surgery
Ljubljana, , Slovenia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Groselj A, Bosnjak M, Jesenko T, Cemazar M, Markelc B, Strojan P, Sersa G. Treatment of skin tumors with intratumoral interleukin 12 gene electrotransfer in the head and neck region: a first-in-human clinical trial protocol. Radiol Oncol. 2022 Aug 14;56(3):398-408. doi: 10.2478/raon-2022-0021.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ERIDEK-0086/2020
Identifier Type: -
Identifier Source: org_study_id