MelanomaPhase 1AMEPNCT01045915
Safety and Efficacy Study of Electrotransfer of Plasmid AMEP to Treat Advanced or Metastatic Melanoma
A Phase 1 study testing naked DNA coding for protein AMEP in people with Melanoma, run by Valerio Therapeutics at 3 sites in 3 countries.
Trial summary
The objective of the present trial is to evaluate the local and general safety of the intratumoural electrotransfer of increasing doses of Plasmid AMEP in patients suffering from advanced or metastatic melanoma and to identify doses that could be effective on cutaneous lesions in man. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Melanoma
- What is being tested?
- naked DNA coding for protein AMEP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jul 2010to Jan 2013
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant, non-breast feeding female;
- Aged between 18 and 75 years;
- Stage IIIB, stage IIIC or stage IV melanoma with:
- At least 2 cutaneous or subcutaneous non necrotic accessible tumours;
- Tumour size of 1 to 1.5 cm diameter;
- No minimum distance between the 2 selected lesions;
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- Progressive melanoma not responding to previous treatments or patients refusing other therapies;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
- For women of child-bearing age: effective contraception method (oral contraception or intra-uterine device) used for more than 2 months before the 1st administration and to be maintained for 3 months after the last administration of Plasmid AMEP;
- Having given a written informed consent.
Who cannot join
- Patients who can benefit from other melanoma treatments including surgery;
- Significant cardiac arrhythmias, electronic pacemakers, defibrillators, or any implanted electronic device;
- Recent (less than 6 months) acute vascular diseases (stroke, MI…);
- Advanced peripheral arterial diseases, venous ulcers, or scleroderma;
- History or treatment of seizures within the last 5 years;
- Clinically significant abnormality at pre-study full physical examination;
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- Any clinically significant ECG abnormalities;
- Prior systemic therapy or any other antineoplastic treatments within the last 4 weeks, radiotherapy or surgery unrelated to the fields in question are allowed;
- Abnormal renal function (creatinine plasma level > ULN);
- Abnormal liver function tests (any of the following):
- PT < 70%, ASAT, ALAT, alkaline phosphatases, GGT and/or total bilirubin > ULN in the absence of liver metastasis;
- PT < 70%, ASAT, ALAT > 2 ULN, alkaline phosphatases > 1.5 ULN, GGT > 5 ULN and/or total bilirubin > 3 ULN in the case of liver metastases;
- Abnormal bone marrow function: haemoglobin < 10g/dL, WBC < 3.109 /L and/or platelet count < 100.103 /L;
- Clinically significant abnormality in pre-study laboratory tests;
- Evidence of significant active infection (e.g., pneumonia, wound abscess, etc);
- Intractable coagulopathy;
- Any significant disease, including psychiatric and dermatology diseases that may affect the proper evaluation of efficacy or safety;
- Patients who had participated in another clinical trial in the last 30 days prior to enrolment in the present clinical trial;
- Patients unwilling or unable to comply with protocol requirements and scheduled visits.
- Note: patients with brain metastases, or waiting for other therapies (i.e. isolated limb perfusion) may be included.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Safety and Efficacy of Intratumoural Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma: an Open Phase 1 Trial
The objective of the present trial is to evaluate the local and general safety of the intratumoural electrotransfer of increasing doses of Plasmid AMEP in patients suffering from advanced or metastatic melanoma and to identify doses that could be effective on cutaneous lesions in man.
Read the detailed description
In this open, multicentre, dose escalation study, successive cohorts of 3 patients suffering from advanced or metastatic melanoma will be electrotransferred increasing doses of Plasmid AMEP into cutaneous melanoma lesions in 2 divided doses at one week interval.
- Conditions
- Melanoma
- Being tested
- naked DNA coding for protein AMEP
- Keywords
- Stage IIIB, stage IIIC or stage IV melanoma, Progressive melanoma not responding to previous treatments
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naked DNA coding for protein AMEPBiological
Also called electrotransfer, electroporation
2 injections 1 week interval of 4 increasing doses of plasmid with electrotransfer
| Study group | Role | What they receive |
|---|---|---|
| Plasmid AMEP electrotransfer | Experimental | Not described Receives: Biological: naked DNA coding for protein AMEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Dose Limiting Toxicity defined as any grade 4 clinical, biological or any life-threatening ECG event occurring during the 9 weeks following treatment
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2012
- Study completionJan 2013
Why it stopped: The study has been halted due to the low enrolment rate.
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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valerio Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ATTALI Pierre, MD, Study director, BioAlliance Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045915
- Sponsor's protocol ID
- BA2009/15/01
- Other IDs
- 2009-013042-88, 2009
- Acronym
- AMEP
- Status last verified
- May 2012
- First submitted
- 8 Jan 2010
- Last updated
- 11 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Intratumoural Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma: an Open Phase 1 Trial
- ClinicalTrials.gov ID
- NCT01045915
- Acronym / sponsor ID
- AMEP / BA2009/15/01
- Conditions
- Melanoma
- Keywords
- Stage IIIB, stage IIIC or stage IV melanoma, Progressive melanoma not responding to previous treatments
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study has been halted due to the low enrolment rate.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Valerio TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 11 Jan 2010 (estimated)
- 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.
The objective of the present trial is to evaluate the local and general safety of the intratumoural electrotransfer of increasing doses of Plasmid AMEP in patients suffering from advanced or metastatic melanoma and to identify doses that could be effective on cutaneous lesions in man.
Detailed description
In this open, multicentre, dose escalation study, successive cohorts of 3 patients suffering from advanced or metastatic melanoma will be electrotransferred increasing doses of Plasmid AMEP into cutaneous melanoma lesions in 2 divided doses at one week interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plasmid AMEP electrotransfer | Experimental | Biological: naked DNA coding for protein AMEP |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or non-pregnant, non-breast feeding female;
- Aged between 18 and 75 years;
- Stage IIIB, stage IIIC or stage IV melanoma with:
- Progressive melanoma not responding to previous treatments or patients refusing other therapies;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
Key exclusion criteria (20 listed)
- Patients who can benefit from other melanoma treatments including surgery;
- Significant cardiac arrhythmias, electronic pacemakers, defibrillators, or any implanted electronic device;
- Recent (less than 6 months) acute vascular diseases (stroke, MI…);
- Advanced peripheral arterial diseases, venous ulcers, or scleroderma;
- History or treatment of seizures within the last 5 years;
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 |
|---|---|---|
| naked DNA coding for protein AMEPAlso: electrotransfer, electroporation2 injections 1 week interval of 4 increasing doses of plasmid with electrotransfer | Biological | Plasmid AMEP electrotransfer |
Primary outcome
Determination of Dose Limiting Toxicity defined as any grade 4 clinical, biological or any life-threatening ECG event occurring during the 9 weeks following treatment
Time frame: 9 weeks
Results and safety
The study was stopped early (reason given: The study has been halted due to the low enrolment rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2015.
- Gene electrotransfer of plasmid antiangiogenic metargidin peptide (AMEP) in disseminated melanoma: safety and efficacy results of a phase I first-in-man study.Link provided by the sponsor.
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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.
ATTALI Pierre, MD study director
BioAlliance Pharma
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing naked DNA coding for protein AMEP in people with Melanoma, run by Valerio Therapeutics at 3 sites in 3 countries.
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 10 inclusion and 20 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 11 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, France, 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 was stopped early (reason given: The study has been halted due to the low enrolment rate.). 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?
Determination of Dose Limiting Toxicity defined as any grade 4 clinical, biological or any life-threatening ECG event occurring during the 9 weeks following treatment (time frame: 9 weeks). 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 11 Sep 2015.