Basal Cell CarcinomaPhase 1SmartGeneH&NNCT05077033
Intratumoral phIL12 GET
A Phase 1 study testing phIL12 GET in people with Basal Cell Carcinoma, run by Institute of Oncology Ljubljana at 2 sites in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- phIL12 GET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesSlovenia
- Study dates
- 28 Sep 2021to 30 Nov 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Slovenia2 sites
Institute of Oncology Ljubljana
Ljubljana, 1000
University Medical Centre Ljubljana, Department of Otorhinolaryngology and Cervicofacial Surgery
Ljubljana, 1000
About this study
Official title: Treatment of Skin Tumours With Intratumoral Interleukin 12 Gene Electrotransfer in the Head and Neck Region
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
- Being tested
- phIL12 GET
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phIL12 GETDrug
intratumoral phIL12 gene electrotransfer
| Study group | Role | What they receive |
|---|---|---|
| Intratumoral phIL12 gene electrotransfer | Experimental | Not described Receives: Drug: phIL12 GET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of acute adverse events
CTCAE v.5.0 criteria
Measured: Adverse events 2 days after the treatment.
Number of adverse events 7 days after the treatment
CTCAE v.5.0 criteria
Measured: Adverse events 7 days after the treatment.
Number of late adverse events
CTCAE v.5.0 criteria
Measured: Adverse events 30 days after the treatment.
Evaluating quality of life with questionnaire one week after the treatment
EORTC QLQ-C30
Measured: Changes from baseline 7 days after the treatment.
Evaluating quality of life with questionnaire one month after the treatment
EORTC QLQ-C30
Measured: Changes from baseline 30 days after the treatment.
Secondary outcomes (2)
Area under the plasma concentration versus time curve (AUC)
Determination of serum levels of IL-12 cytokine.
Measured: Changes from baseline at 2, 7 and 30 days after the treatment.
Concentrations of IL-12 and IFN-y in tumor samples
Determination of tumor IL-12 and IFN-y levels in tumor biopsies.
Measured: Changes from baseline at 7 and 30 days after the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start28 Sep 2021
- Primary completion1 Sep 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077033
- Sponsor's protocol ID
- ERIDEK-0086/2020
- Acronym
- SmartGeneH&N
- Status last verified
- Dec 2023
- First submitted
- 24 Sep 2021
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35535423
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Skin Tumours With Intratumoral Interleukin 12 Gene Electrotransfer in the Head and Neck Region
- ClinicalTrials.gov ID
- NCT05077033
- Acronym / sponsor ID
- SmartGeneH&N / ERIDEK-0086/2020
- Conditions
- Basal Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intratumoral phIL12 gene electrotransfer | Experimental | Drug: phIL12 GET |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phIL12 GETintratumoral phIL12 gene electrotransfer | Drug | Intratumoral phIL12 gene electrotransfer |
Primary outcome
Number of acute adverse events
Time frame: Adverse events 2 days after the treatment.
CTCAE v.5.0 criteria
Number of adverse events 7 days after the treatment
Time frame: Adverse events 7 days after the treatment.
CTCAE v.5.0 criteria
Number of late adverse events
Time frame: Adverse events 30 days after the treatment.
CTCAE v.5.0 criteria
Evaluating quality of life with questionnaire one week after the treatment
Time frame: Changes from baseline 7 days after the treatment.
EORTC QLQ-C30
Evaluating quality of life with questionnaire one month after the treatment
Time frame: Changes from baseline 30 days after the treatment.
EORTC QLQ-C30
2 secondary outcomes
Area under the plasma concentration versus time curve (AUC)
Time frame: Changes from baseline at 2, 7 and 30 days after the treatment.
Concentrations of IL-12 and IFN-y in tumor samples
Time frame: Changes from baseline at 7 and 30 days after the treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Background: PubMed 35535423Groselj 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 InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing phIL12 GET in people with Basal Cell Carcinoma, run by Institute of Oncology Ljubljana at 2 sites in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of acute adverse events (time frame: Adverse events 2 days after the treatment.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05077033, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.