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Intratumoral phIL12 GET (SmartGeneH&N)

Primary Purpose

Basal Cell Carcinoma

Status
Recruiting
Phase
Phase 1
Locations
Slovenia
Study Type
Interventional
Intervention
phIL12 GET
Sponsored by
Institute of Oncology Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Basal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute of Oncology LjubljanaRecruiting
  • University Medical Centre Ljubljana, Department of Otorhinolaryngology and Cervicofacial SurgeryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intratumoral phIL12 gene electrotransfer

Arm Description

Outcomes

Primary Outcome Measures

Number of acute adverse events
CTCAE v.5.0 criteria
Number of adverse events 7 days after the treatment
CTCAE v.5.0 criteria
Number of late adverse events
CTCAE v.5.0 criteria
Evaluating quality of life with questionnaire one week after the treatment
EORTC QLQ-C30
Evaluating quality of life with questionnaire one month after the treatment
EORTC QLQ-C30

Secondary Outcome Measures

Area under the plasma concentration versus time curve (AUC)
Determination of serum levels of IL-12 cytokine.
Concentrations of IL-12 and IFN-y in tumor samples
Determination of tumor IL-12 and IFN-y levels in tumor biopsies.

Full Information

First Posted
September 24, 2021
Last Updated
November 8, 2022
Sponsor
Institute of Oncology Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT05077033
Brief Title
Intratumoral phIL12 GET
Acronym
SmartGeneH&N
Official Title
Treatment of Skin Tumours With Intratumoral Interleukin 12 Gene Electrotransfer in the Head and Neck Region
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2021 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Oncology Ljubljana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intratumoral phIL12 gene electrotransfer
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
phIL12 GET
Intervention Description
intratumoral phIL12 gene electrotransfer
Primary Outcome Measure Information:
Title
Number of acute adverse events
Description
CTCAE v.5.0 criteria
Time Frame
Adverse events 2 days after the treatment.
Title
Number of adverse events 7 days after the treatment
Description
CTCAE v.5.0 criteria
Time Frame
Adverse events 7 days after the treatment.
Title
Number of late adverse events
Description
CTCAE v.5.0 criteria
Time Frame
Adverse events 30 days after the treatment.
Title
Evaluating quality of life with questionnaire one week after the treatment
Description
EORTC QLQ-C30
Time Frame
Changes from baseline 7 days after the treatment.
Title
Evaluating quality of life with questionnaire one month after the treatment
Description
EORTC QLQ-C30
Time Frame
Changes from baseline 30 days after the treatment.
Secondary Outcome Measure Information:
Title
Area under the plasma concentration versus time curve (AUC)
Description
Determination of serum levels of IL-12 cytokine.
Time Frame
Changes from baseline at 2, 7 and 30 days after the treatment.
Title
Concentrations of IL-12 and IFN-y in tumor samples
Description
Determination of tumor IL-12 and IFN-y levels in tumor biopsies.
Time Frame
Changes from baseline at 7 and 30 days after the treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gregor Sersa, PhD
Phone
+386 (0)1 5879 434
Email
gsersa@onko-i.si
First Name & Middle Initial & Last Name or Official Title & Degree
Primoz Strojan, PhD
Phone
+386 (0)1 5879 290
Email
pstrojan@onko-i.si
Facility Information:
Facility Name
Institute of Oncology Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Primoz Strojan, PhD, MD
Phone
+386 (0)1 5879 290
Email
pstrojan@onko-i.si
First Name & Middle Initial & Last Name & Degree
Primoz Strojaan, PhD, MD
First Name & Middle Initial & Last Name & Degree
Gregor Sersa, PhD
First Name & Middle Initial & Last Name & Degree
Maja Cemazar, PhD
First Name & Middle Initial & Last Name & Degree
Tanja Jesenko, PhD
First Name & Middle Initial & Last Name & Degree
Masa Bosnjak, PhD
First Name & Middle Initial & Last Name & Degree
Bostjan Markelc, PhD
First Name & Middle Initial & Last Name & Degree
Ursa Lampreht Tratar, PhD
First Name & Middle Initial & Last Name & Degree
Kloboves Veronika, PhD
First Name & Middle Initial & Last Name & Degree
Gasljevic Gorana, PhD
First Name & Middle Initial & Last Name & Degree
Andreja Brozic, PhD
First Name & Middle Initial & Last Name & Degree
Nina Boc, MD
First Name & Middle Initial & Last Name & Degree
Urska Kamensek, PhD
Facility Name
University Medical Centre Ljubljana, Department of Otorhinolaryngology and Cervicofacial Surgery
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ales Groselj, MD, PhD
Phone
+386 (0)1 5222 153
Email
ales.groselj@kclj.si
First Name & Middle Initial & Last Name & Degree
Ales Groselj, PhD, MD
First Name & Middle Initial & Last Name & Degree
Crt Jamsek, MD
First Name & Middle Initial & Last Name & Degree
Aleksandar Anicin, PhD, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35535423
Citation
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.
Results Reference
background
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/35535423/
Description
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Intratumoral phIL12 GET

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