MelanomaEarly Phase 1IGTM-101NCT03338777
Suicide Plus Immune Gene Therapy for Advanced Melanoma
A Early Phase 1 study testing Suicide plus immunogene therapy in people with Melanoma, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
Safety evaluation of combined immunogene therapy in patients with advanced melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Suicide plus immunogene therapy
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteArgentina
- Study dates
- 20 Feb 2020to 20 Feb 2020
- Phase
- Early 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
- Patients with histologically and / or cytologically confirmed melanoma.
- Patients progressed or are intolerant to conventional systemic treatments.
- Patients that are not candidates for surgery under oncologic criteria (complete resection).
- Performance status (ECOG) 0 or 1.
- Patients with life expectancy greater than 6 months.
- Patients with at least one accessible target lesion for gene inoculation (superficial localizations of the primary tumor, satelitosis, subcutaneous or accessible lymph node metastasis).
- Patients with measurable disease (according to RECIST 1.1 criteria, irrespective of the target lesion chosen for suicide gene inoculation)
- Patients with signed informed consent.
Who cannot join
- Patients with uncontrolled cardiovascular disease
- Patients with uncontrolled respiratory disease.
- Patients with uncontrolled immune disease.
- Patients with glucocorticoids or immunosuppressive drugs or agents with immunomodulatory activity (except non-steroidal anti-inflammatory agents) up to 2 weeks before treatment.
- Patients performing other experimental therapies.
- Patients who are pregnant or breastfeeding.
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- Patients undergoing concurrent chemotherapy or radiation therapy.
- Uncontrolled diabetes.
- Patients with active diagnosis of other malignant neoplasms.
- HIV-positive patients.
- Uncontrolled thyroid abnormality.
- Patients with significant medical morbidity.
- Patients with a history of allergic reactions to chemicals or similar to those used in this study.
- Metastasis in the central nervous system.
- Laboratory eligibility criteria excluded:
- Hemoglobin: <8 g / dL, leukocytes: <3,000 / mm3, platelets: <100,000 / mm3, neutrophils: <1000 / mm3, hematocrit: <25%. bilirubin> 2.0 mg / dL, GOT or GPT: 2.5 times> than normal upper institutional limit (ULN), alkaline phosphatase: 2 times> ULN, creatinine> 2.0 mg / dL, creatinine clearence : <60 ml / min / 1.73 m2.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Italiano
Ciudad Autónoma de Buenos Aires, Buenos Aires
About this study
Official title: Phase 1 Suicide Plus Immune Gene Therapy for Advanced Melanoma
Safety evaluation of combined immunogene therapy in patients with advanced melanoma.
Read the detailed description
This phase I clinical protocol is proposed to evaluate the safety of combined immunotherapy genetics in humans.
This treatment combines the high local cytotoxicity of the suicide gene system (HSV thymidine kinase: HSVt k) / prodrug (ganciclovir: GCV) with the immunostimulation of interleukin2 (hIL2) and immunoamplification of granulocyte and macrophage colony stimulating factor (hGMCSF) in the presence of tumor antigens.
The proposed scheme consists in the periodic intra / peritumoral application of plasmid DNA complexes: cationic lipid (lipoplexes) containing the HSVtk gene, co-administered with the prodrug GCV, and subcutaneous injections of a vaccine (LGvax) produced with formolized extracts of allogeneic melanoma combined with lipoplexes carrying the hIL2 and hGMCSF genes.
- Conditions
- Melanoma
- Being tested
- Suicide plus immunogene therapy
- Keywords
- melanoma, lipoplexes, plasmid, herpes simplex thymidine kinase, interleukin-2, granulocyte-macrophage colony-stimulating factor, tumor vaccine, suicide gene
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suicide plus immunogene therapyBiological
- Intra and peritumoral infiltrates with multiple injections of 0.1 ml/cm2 or 0.2 ml/cm3 of lipoplexes bearing the HSVtk suicide gene (1: 1; 1 mg/ml, according to tumor size), co-administered with GCV (12.5 mg/ml). Patients start with a minimum of 0.5 ml and at the 3rd week, the maximum dose is scaled according to the tumor size up to 2 ml maximum.
- Treated simultaneously with a subcutaneous vaccine produced with:
- Formolized allogeneic tumor extracts and,
- Lipoplexes carrying hIL-2 and hGM-CSF genes (0.5 mg each).
| Study group | Role | What they receive |
|---|---|---|
| Suicide plus immunogene therapy | Experimental | Intra and peritumoral infiltrates with multiple injections of lipoplexes carrying the HSVtk suicide gene co-administered with GCV and subcutaneous vaccine produced with formolized allogeneic tumor extracts and lipoplexes carrying hIL-2 and hGM-CSF genes. Receives: Biological: Suicide plus immunogene therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety reported as the number of treatment-related adverse events as assessed by CTCAE v4.03
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start20 Feb 2020
- Primary completion20 Feb 2020
- Study completion20 Feb 2020
Why it stopped: Failure to achieve primary objective
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Suicide plus immunogene therapy
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Oncología Ángel H. Roffo, National Agency for Scientific and Technological Promotion, Argentina, National Council of Scientific and Technical Research, Argentina, University of Buenos Aires
- Responsible party
- Principal investigator, Simonovich Ventura, MD, Hospital Italiano de Buenos Aires
- Investigators
- Ventura Simonovich, MD, Principal investigator, Hospital Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338777
- Sponsor's protocol ID
- 2082
- Acronym
- IGTM-101
- Status last verified
- Feb 2020
- First submitted
- 10 Oct 2017
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Suicide Plus Immune Gene Therapy for Advanced Melanoma
- ClinicalTrials.gov ID
- NCT03338777
- Acronym / sponsor ID
- IGTM-101 / 2082
- Conditions
- Melanoma
- Keywords
- melanoma, lipoplexes, plasmid, herpes simplex thymidine kinase, interleukin-2, granulocyte-macrophage colony-stimulating factor, tumor vaccine, suicide gene
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to achieve primary objective
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Collaborators
- Instituto de Oncología Ángel H. Roffo, National Agency for Scientific and Technological Promotion, Argentina, National Council of Scientific and Technical Research, Argentina, University of Buenos Aires
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 9 Nov 2017 (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.
Safety evaluation of combined immunogene therapy in patients with advanced melanoma.
Detailed description
This phase I clinical protocol is proposed to evaluate the safety of combined immunotherapy genetics in humans.
This treatment combines the high local cytotoxicity of the suicide gene system (HSV thymidine kinase: HSVt k) / prodrug (ganciclovir: GCV) with the immunostimulation of interleukin2 (hIL2) and immunoamplification of granulocyte and macrophage colony stimulating factor (hGMCSF) in the presence of tumor antigens.
The proposed scheme consists in the periodic intra / peritumoral application of plasmid DNA complexes: cationic lipid (lipoplexes) containing the HSVtk gene, co-administered with the prodrug GCV, and subcutaneous injections of a vaccine (LGvax) produced with formolized extracts of allogeneic melanoma combined with lipoplexes carrying the hIL2 and hGMCSF genes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Suicide plus immunogene therapy
| Arm | Type | Receives |
|---|---|---|
| Suicide plus immunogene therapy | Experimental | Biological: Suicide plus immunogene therapyIntra and peritumoral infiltrates with multiple injections of lipoplexes carrying the HSVtk suicide gene co-administered with GCV and subcutaneous vaccine produced with formolized allogeneic tumor extracts and lipoplexes carrying hIL-2 and hGM-CSF genes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with histologically and / or cytologically confirmed melanoma.
- Patients progressed or are intolerant to conventional systemic treatments.
- Patients that are not candidates for surgery under oncologic criteria (complete resection).
- Performance status (ECOG) 0 or 1.
- Patients with life expectancy greater than 6 months.
Key exclusion criteria (16 listed)
- Patients with uncontrolled cardiovascular disease
- Patients with uncontrolled respiratory disease.
- Patients with uncontrolled immune disease.
- Patients with glucocorticoids or immunosuppressive drugs or agents with immunomodulatory activity (except non-steroidal anti-inflammatory agents) up to 2 weeks before treatment.
- Patients performing other experimental therapies.
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 |
|---|---|---|
| Suicide plus immunogene therapy1. Intra and peritumoral infiltrates with multiple injections of 0.1 ml/cm2 or 0.2 ml/cm3 of lipoplexes bearing the HSVtk suicide gene (1: 1; 1 mg/ml, according to tumor size), co-administered with GCV (12.5 mg/ml). Patients start with a minimum of 0.5 ml and at the 3rd week, the maximum dose is scaled according to the tumor size up to 2 ml maximum. 2. Treated simultaneously with a subcutaneous vaccine produced with: * Formolized allogeneic tumor extracts and, * Lipoplexes carrying hIL-2 and hGM-CSF genes (0.5 mg each). | Biological | Suicide plus immunogene therapy |
Primary outcome
Safety reported as the number of treatment-related adverse events as assessed by CTCAE v4.03
Time frame: 1 year
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf).
Results and safety
The study was stopped early (reason given: Failure to achieve primary objective). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- 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.
Ventura Simonovich, MD principal investigator
Hospital Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Suicide plus immunogene therapy in people with Melanoma, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 16 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: stopped early, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early (reason given: Failure to achieve primary objective). Results are not available in the source record.
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?
Safety reported as the number of treatment-related adverse events as assessed by CTCAE v4.03 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2020.