MelanomaPhase 1/2AIMMNCT01764009
Safety and Efficacy of Intramuscular Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma
A Phase 1/2 study testing naked DNA coding for protein AMEP in people with Melanoma, run by Valerio Therapeutics at 4 sites in 2 countries.
Trial summary
The objective of the present trial is: to determine the dose limiting toxicity (DLT), maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of intramuscular electrotransferred Plasmid AMEP in patients with advanced or metastatic 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?
- 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
- 0 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jun 2012to Mar 2014
- Phase
- Phase 1/2
- 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
- Aged over 18 years
- Patient with histologically or cytologically confirmed melanoma
- Patient with unresectable advanced or metastatic (stage III or IV) melanoma
- Patient with progressive melanoma (any BRAF status is permitted) not responding or intolerant to previous treatments, including patients with asymptomatic and not rapidly progressive brain metastases.
- Patient with a minimum of one measurable lesion according to RECIST guideline 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Patient having given a written informed consent
Who cannot join
- Patient eligible for curative treatments and/or any palliative treatments with demonstrated efficacy, including current treatments for brain metastasis, and including available BRAF inhibitors as indicated for patients carrying B-RAF mutated tumours if applicable.
- Patient with history of any other cancer within five years before enrollment (except cured basal cell carcinoma or cervical cancer in situ)
- Patient with inadequate organ function, defined as:
- Platelet count < 75.103 /L (> grade 2 NCI CTCAE)
- Absolute neutrophil count < 1.109 /L (> grade 2)
- Hemoglobin < 9 g/dL
Show all 27Show fewer
- INR increased or prolonged activated partial thromboplastin time (aPTT) upper the limit of normal (ULN) (≥ grade 1)
- Creatinine clearance < 60 mL/min (Cockcroft and Gault formula) (≥ grade 2)
- Patient with ALT > 3 ULN (≥ grade 2) or patient with symptomatic liver metastasis with ALT > 5 ULN (> grade 2)
- Serum Total Bilirubin > 1.5 ULN (≥ grade 2); Patient with Gilbert's syndrome could be included if hyperbilirubinemia ≤ 3 ULN
- Not medically controlled coagulation disorder (i.e hemophilia, protein C or S deficiency…)
- Patient with electronic pacemakers, defibrillators, or any implanted electronic device
- Any cardiac dysrhythmia (> grade 2) (i.e significant ventricular arrhythmia as persistent ventricular tachycardia and/or ventricular fibrillation; severe conduction disorders as atrio-ventricular block 2 and 3, sino-atrial block)
- Recent (less than 6 months) acute vascular diseases (i.e stroke, myocardial infarction)
- Arterial vascular disorders ≥ grade 2
- Serious, non-healed wound, ulcer or bone fracture
- Significant traumatic injury within 28 days prior to study treatment start or anticipation of the need for major surgery during study treatment
- Evidence of ongoing or active viral or bacterial infection ( i.e bacterial infection requiring IV antibiotics)
- Patient with life expectancy less than 3 months
- Prior systemic therapy or any other antineoplastic treatments within the last 4 weeks, including radiotherapy or surgery
- Patients who had participated in another clinical trial in the last 30 days prior to enrolment in the present clinical trial
- Man and woman of child-bearing age without effective contraception method during the study and for 3 months after the last administration of Plasmid AMEP (i.e oral contraception or intra-uterine device for woman; i.e condom for man)
- Pregnant or nursing women
- Any significant disease, including psychiatric and neuromuscular disease, which may affect the proper evaluation of safety or efficacy or may affect ability to give informed consent
- Patients unwilling or unable to comply with protocol requirements and scheduled visits
- For contrast enhanced ultrasound (CEUS): known contraindications to SonoVue as described in the summary product characteristics (i.e cardiac or pulmonary history, hypersensitivity to sulphur hexafluoride or to any of the components of SonoVue)
- For the part II: prophylactic phenytoin in combination with dacarbazine.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
France3 sites
Gustave Roussy Institute,
Le Kremlin-Bicêtre, 94805
Hôpital Saint Louis. Service de dermatologie
Paris, 75010
CHU Nancy Hôpital Brabois
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Safety and Efficacy of Intramuscular Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma: an Open-label Phase I/II Clinical Trial - The AIMM Study (AMEP In Metastatic Melanoma)
The objective of the present trial is:
- to determine the dose limiting toxicity (DLT), maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of intramuscular electrotransferred Plasmid AMEP in patients with advanced or metastatic melanoma.
- to determine the local and general safety of intramuscular electrotransferred Plasmid AMEP
- to evaluate the efficacy of intramuscular electrotransferred Plasmid AMEP
Read the detailed description
In this open-label, multicentre, dose escalation phase I study, successive cohorts of 3 patients suffering from advanced or metastatic melanoma will be electrotransferred increasing doses of Plasmid AMEP into muscle. Treatment will be repeated every 28 days until progression or limiting toxicity.
Consecutive cohorts of 3 to 6 patients will be treated with increasing doses of Plasmid AMEP at three dose levels: 0.25 mg, 1 mg and 4 mg according to an adapted 3+3 design. There will be no intra-patient dose escalation.
- Conditions
- Melanoma
- Being tested
- naked DNA coding for protein AMEP
- Keywords
- Advanced Melanoma, Metastatic Melanoma, Melanoma Stage III and IV
- 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
injections 28days interval of 3 increasing doses of plasmid with electrotransfer
| Study group | Role | What they receive |
|---|---|---|
| Plasmid AMEP electrotransfer in muscle | 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.
Safety-Dose Limiting toxicity determination
Dose Limiting Toxicity (DLT) defined as any grade 4 clinical or biological event related to the study treatment and occurring during the first and second course (8 weeks) Safety parameters will be assessed according to the NCI-CTCAE v4.0 classification
Measured: 8 weeks
Secondary outcomes (1)
Safety- determination of the repeated dose
Main secondary endpoints will be safety parameters; the evaluation of efficacy parameters will allow identifying preliminary efficacy of Plasmid AMEP alone and determining the RP2D.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startJun 2012
- Primary completionDec 2013
- Study completionMar 2014
Why it stopped: Study stopped due to 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valerio Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bérangère VASSEUR, M.D., Study director, BioAlliance Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764009
- Sponsor's protocol ID
- BA2011/15/02
- Other IDs
- 2011-005538-20
- Acronym
- AIMM
- Status last verified
- Sep 2015
- First submitted
- 7 Jan 2013
- 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 Intramuscular Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma: an Open-label Phase I/II Clinical Trial - The AIMM Study (AMEP In Metastatic Melanoma)
- ClinicalTrials.gov ID
- NCT01764009
- Acronym / sponsor ID
- AIMM / BA2011/15/02
- Conditions
- Melanoma
- Keywords
- Advanced Melanoma, Metastatic Melanoma, Melanoma Stage III and IV
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study stopped due to low enrolment rate.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Valerio TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 9 Jan 2013 (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 determine the dose limiting toxicity (DLT), maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of intramuscular electrotransferred Plasmid AMEP in patients with advanced or metastatic melanoma.
- to determine the local and general safety of intramuscular electrotransferred Plasmid AMEP
- to evaluate the efficacy of intramuscular electrotransferred Plasmid AMEP
Detailed description
In this open-label, multicentre, dose escalation phase I study, successive cohorts of 3 patients suffering from advanced or metastatic melanoma will be electrotransferred increasing doses of Plasmid AMEP into muscle. Treatment will be repeated every 28 days until progression or limiting toxicity.
Consecutive cohorts of 3 to 6 patients will be treated with increasing doses of Plasmid AMEP at three dose levels: 0.25 mg, 1 mg and 4 mg according to an adapted 3+3 design. There will be no intra-patient dose escalation.
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 in muscle | Experimental | Biological: naked DNA coding for protein AMEP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged over 18 years
- Patient with histologically or cytologically confirmed melanoma
- Patient with unresectable advanced or metastatic (stage III or IV) melanoma
- Patient with progressive melanoma (any BRAF status is permitted) not responding or intolerant to previous treatments, including patients with asymptomatic and not rapidly progressive brain metastases.
- Patient with a minimum of one measurable lesion according to RECIST guideline 1.1
Key exclusion criteria (27 listed)
- Patient eligible for curative treatments and/or any palliative treatments with demonstrated efficacy, including current treatments for brain metastasis, and including available BRAF inhibitors as indicated for patients carrying B-RAF mutated tumours if applicable.
- Patient with history of any other cancer within five years before enrollment (except cured basal cell carcinoma or cervical cancer in situ)
- Patient with inadequate organ function, defined as:
- Platelet count < 75.103 /L (> grade 2 NCI CTCAE)
- Absolute neutrophil count < 1.109 /L (> grade 2)
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, electroporationinjections 28days interval of 3 increasing doses of plasmid with electrotransfer | Biological | Plasmid AMEP electrotransfer in muscle |
Primary outcome
Safety-Dose Limiting toxicity determination
Time frame: 8 weeks
Dose Limiting Toxicity (DLT) defined as any grade 4 clinical or biological event related to the study treatment and occurring during the first and second course (8 weeks) Safety parameters will be assessed according to the NCI-CTCAE v4.0 classification
1 secondary outcome
Safety- determination of the repeated dose
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2015.
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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.
Bérangère VASSEUR, M.D. study director
BioAlliance Pharma
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing naked DNA coding for protein AMEP in people with Melanoma, run by Valerio Therapeutics at 4 sites in 2 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 7 inclusion and 27 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: withdrawn, 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 4 sites in 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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-Dose Limiting toxicity determination (time frame: 8 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.