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

This study has been terminated.
(The study has been halted due to the low enrolment rate.)
Sponsor:
Information provided by (Responsible Party):
BioAlliance Pharma SA
ClinicalTrials.gov Identifier:
NCT01045915
First received: January 8, 2010
Last updated: January 7, 2013
Last verified: May 2012
  Purpose

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 Intervention Phase
Melanoma
Biological: naked DNA coding for protein AMEP
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by BioAlliance Pharma SA:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: July 2010
Estimated Study Completion Date: January 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01045915

Locations
Denmark
Copenhagen University Hospital Herlev
Herlev, Denmark, 2730
France
Gustave Roussy Institute
Kremlin Bicetre, France, 94805
Slovenia
Institute of Oncology Ljubljana
Ljubljana, Slovenia, SI-1000
Sponsors and Collaborators
BioAlliance Pharma SA
Investigators
Study Director: ATTALI Pierre, MD BioAlliance Pharma
  More Information

No publications provided

Responsible Party: BioAlliance Pharma SA
ClinicalTrials.gov Identifier: NCT01045915     History of Changes
Other Study ID Numbers: BA2009/15/01, 2009-013042-88
Study First Received: January 8, 2010
Last Updated: January 7, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Denmark: Danish Medicines Agency
Slovenia: Agency for Medicinal Products - Ministry of Health

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

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

ClinicalTrials.gov processed this record on August 27, 2014