Intratumoral phIL12 GET

NCT05077033 | Completed Phase 1 DMC

• 1 other identifier: ERIDEK-0086/2020
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (5)

• Number of acute adverse events

  CTCAE v.5.0 criteria

  Adverse events 2 days after the treatment.

• Number of adverse events 7 days after the treatment

  CTCAE v.5.0 criteria

  Adverse events 7 days after the treatment.

• Number of late adverse events

  CTCAE v.5.0 criteria

  Adverse events 30 days after the treatment.

• Evaluating quality of life with questionnaire one week after the treatment

  EORTC QLQ-C30

  Changes from baseline 7 days after the treatment.

• Evaluating quality of life with questionnaire one month after the treatment

  EORTC QLQ-C30

  Changes from baseline 30 days after the treatment.

Secondary Outcomes (2)

• Area under the plasma concentration versus time curve (AUC)

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

• Concentrations of IL-12 and IFN-y in tumor samples

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

Study Arms (1)

Intratumoral phIL12 gene electrotransfer

EXPERIMENTAL

Drug: phIL12 GET

Interventions

phIL12 GET DRUG

intratumoral phIL12 gene electrotransfer

Intratumoral phIL12 gene electrotransfer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (2)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

University Medical Centre Ljubljana, Department of Otorhinolaryngology and Cervicofacial Surgery

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

• 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.

  PMID: 35535423 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: October 13, 2021
• Study Start: September 28, 2021
• Primary Completion: September 1, 2023
• Study Completion: November 30, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

SL (2)