Safety and Efficacy of Intramuscular Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma (AIMM)
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
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- Safety-Dose Limiting toxicity determination [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]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
- Safety- determination of the repeated dose [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]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.
- tolerability [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Local tolerability of the intramuscular electrotransfer of Plasmid AMEP
- Overall tolerability: incidence, nature and severity of adverse events and serious adverse events
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Experimental: Plasmid AMEP electrotransfer in muscle||
Biological: naked DNA coding for protein AMEP
injections 28days interval of 3 increasing doses of plasmid with electrotransfer
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.
|Gustave Roussy Institute,|
|Kremlin Bicetre, France, 94805|
|Hôpital Saint Louis. Service de dermatologie|
|Paris, France, 75010|
|CHU Nancy Hôpital Brabois|
|Vandoeuvre Les Nancy, France, 54511|
|Institute of Oncology Ljubljana|
|Ljubljana, Slovenia, SI-1000|
|Study Director:||Bérangère VASSEUR, M.D.||BioAlliance Pharma|