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NCT Number: NCT05077033

Intratumoral phIL12 GET

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.

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Key information

Conditions

Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Institute of Oncology Ljubljana, Ljubljana, Slovenia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 - 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.

Treatment and study plan

phIL12 GET

Drug

intratumoral phIL12 gene electrotransfer

Primary outcomes

  1. Number of acute adverse events

    Time frame: Adverse events 2 days after the treatment.

    CTCAE v.5.0 criteria

  2. Number of adverse events 7 days after the treatment

    Time frame: Adverse events 7 days after the treatment.

    CTCAE v.5.0 criteria

  3. Number of late adverse events

    Time frame: Adverse events 30 days after the treatment.

    CTCAE v.5.0 criteria

  4. Evaluating quality of life with questionnaire one week after the treatment

    Time frame: Changes from baseline 7 days after the treatment.

    EORTC QLQ-C30

  5. Evaluating quality of life with questionnaire one month after the treatment

    Time frame: Changes from baseline 30 days after the treatment.

    EORTC QLQ-C30

Secondary outcomes

  1. Area under the plasma concentration versus time curve (AUC)

    Time frame: Changes from baseline at 2, 7 and 30 days after the treatment.

    Determination of serum levels of IL-12 cytokine.

  2. Concentrations of IL-12 and IFN-y in tumor samples

    Time frame: Changes from baseline at 7 and 30 days after the treatment.

    Determination of tumor IL-12 and IFN-y levels in tumor biopsies.

Sponsors and collaborators

Lead sponsor

Institute of Oncology Ljubljana

Other

Registry information

Official study title

Treatment of Skin Tumours With Intratumoral Interleukin 12 Gene Electrotransfer in the Head and Neck Region

Acronym: SmartGeneH&N

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 13, 2021
Registry last updated
Dec 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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