Treatment of skin cancer using gene therapy with intratumoral gene electrotransfer of a plasmid coding for IL-12

Phase 1

Completed

• Conditions: Basal cell carcinoma of the skin in the head and neck region; Cancer

• Registration Number: ISRCTN15479959
• Lead Sponsor: Institute of Oncology Ljubljana

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35535423/ (added 07/11/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-29
• Study Completion: 2023-12-31
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

1. Histologically or cytologically confirmed, previously untreated cutaneous basal cell carcinoma located in head and neck region
2. Solitary tumours, with the largest diameter up to 3 cm, in the region where curative surgery is feasible
3. Age 18 years or older
4. Life expectancy >3 months
5. Physical performance in accordance with the Karnofsky scale =70 or <2 in accordance with World Health Organization (WHO) scale
6. The patient must be capable of understanding the treatment procedure and possible adverse events, which may arise during treatment
7. The patient must be capable of signing the informed consent to participate in the clinical study (voluntary and conscientious consent after education)
8. Prior to inclusion in the trial, the patient must be presented at a multidisciplinary advisory team meeting

Exclusion Criteria

1. Known malignancy elsewhere in/on the body
2. Lesions not suitable for treatment with GET (invasion into the bone, infiltration of large vessels)
3. A life-threatening infection and/or severe heart failure and/or liver failure and/or other life-threatening systemic diseases
4. Significantly reduced lung function, which requires the determination of diffusing capacity for carbon monoxide (DLCO). Patients should not be treated if DLCO is abnormal
5. Treatment with immunosuppressive drugs, steroids and other drugs that would affect poor wound healing
6. Age under 18-years
7. Major disruptions in the coagulation system (who does not respond to the standard therapy – replacement of vitamin K or freshly frozen plasma)
8. A chronic decline in kidney function (creatinine >150 µmol/l)
9. Epilepsy
10. Pregnancy and breastfeeding
11. Patient’s incapable of comprehending the purpose or course of the trial, or not agreeing to be included in the trial
12. Patients unwilling or unable to comply with the protocol requirements and scheduled visits

Study & Design

• Study Type: Interventional
• Study Design: Not specified