Working... Menu
Trial record 1 of 1 for:    NCT01045915
Previous Study | Return to List | Next Study

Safety and Efficacy Study of Electrotransfer of Plasmid AMEP to Treat Advanced or Metastatic Melanoma (AMEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01045915
Recruitment Status : Terminated (The study has been halted due to the low enrolment rate.)
First Posted : January 11, 2010
Last Update Posted : September 11, 2015
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
Melanoma Biological: naked DNA coding for protein AMEP Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Intratumoural Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma: an Open Phase 1 Trial
Study Start Date : July 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Plasmid AMEP electrotransfer Biological: naked DNA coding for protein AMEP
2 injections 1 week interval of 4 increasing doses of plasmid with electrotransfer
Other Names:
  • electrotransfer
  • electroporation

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or non-pregnant, non-breast feeding female;
  2. Aged between 18 and 75 years;
  3. 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;
  4. Progressive melanoma not responding to previous treatments or patients refusing other therapies;
  5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
  6. 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;
  7. Having given a written informed consent.

Exclusion Criteria:

  1. Patients who can benefit from other melanoma treatments including surgery;
  2. Significant cardiac arrhythmias, electronic pacemakers, defibrillators, or any implanted electronic device;
  3. Recent (less than 6 months) acute vascular diseases (stroke, MI…);
  4. Advanced peripheral arterial diseases, venous ulcers, or scleroderma;
  5. History or treatment of seizures within the last 5 years;
  6. Clinically significant abnormality at pre-study full physical examination;
  7. Any clinically significant ECG abnormalities;
  8. Prior systemic therapy or any other antineoplastic treatments within the last 4 weeks, radiotherapy or surgery unrelated to the fields in question are allowed;
  9. Abnormal renal function (creatinine plasma level > ULN);
  10. 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;
  11. Abnormal bone marrow function: haemoglobin < 10g/dL, WBC < 3.109 /L and/or platelet count < 100.103 /L;
  12. Clinically significant abnormality in pre-study laboratory tests;
  13. Evidence of significant active infection (e.g., pneumonia, wound abscess, etc);
  14. Intractable coagulopathy;
  15. Any significant disease, including psychiatric and dermatology diseases that may affect the proper evaluation of efficacy or safety;
  16. Patients who had participated in another clinical trial in the last 30 days prior to enrolment in the present clinical trial;
  17. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01045915

Layout table for location information
Copenhagen University Hospital Herlev
Herlev, Denmark, 2730
Gustave Roussy Institute
Kremlin Bicetre, France, 94805
Institute of Oncology Ljubljana
Ljubljana, Slovenia, SI-1000
Sponsors and Collaborators
Layout table for investigator information
Study Director: ATTALI Pierre, MD BioAlliance Pharma

Additional Information:
Layout table for additonal information
Responsible Party: Onxeo Identifier: NCT01045915     History of Changes
Other Study ID Numbers: BA2009/15/01
2009-013042-88 ( Registry Identifier: EudraCT number )
First Posted: January 11, 2010    Key Record Dates
Last Update Posted: September 11, 2015
Last Verified: May 2012

Keywords provided by Onxeo:
Stage IIIB, stage IIIC or stage IV melanoma
Progressive melanoma not responding to previous treatments

Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas