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

September 10, 2015 updated by: Onxeo

Safety and Efficacy of Intratumoural Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma: an Open Phase 1 Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark, 2730
        • Copenhagen University Hospital Herlev
  • France
      • Kremlin Bicetre, France, 94805
        • Gustave Roussy Institute
  • Slovenia
      • Ljubljana, Slovenia, SI-1000
        • Institute of Oncology Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Onxeo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ATTALI Pierre, MD, BioAlliance Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BA2009/15/01
  • 2009-013042-88 (Registry Identifier: EudraCT number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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