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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)

Phase 1/Phase 2
18 Years
Open (Enrolling)

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Trial Information

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)

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- 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

- Patient with electronic pacemakers, defibrillators, or any implanted electronic

- 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

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety-Dose Limiting toxicity determination

Outcome Description:

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

Outcome Time Frame:

8 weeks

Safety Issue:


Principal Investigator

Bérangère VASSEUR, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

BioAlliance Pharma


France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:




Start Date:

Completion Date:

March 2014

Related Keywords:

  • Melanoma
  • Advanced Melanoma
  • Metastatic Melanoma
  • Melanoma Stage III and IV
  • Melanoma
  • Stress, Psychological