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

Melanoma Clinical Trial

— AMEP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01045915
• Other study ID #: BA2009/15/01
• Secondary ID: 2009-013042-88
• Status: Terminated
• Phase: Phase 1
• First received: January 8, 2010
• Last updated: September 10, 2015
• Start date: July 2010
• Est. completion date: January 2013

Study information

• Verified date: May 2012
• Source: Onxeo
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Denmark: Danish Medicines AgencySlovenia: Agency for Medicinal Products - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Biological:
• naked DNA coding for protein AMEP
2 injections 1 week interval of 4 increasing doses of plasmid with electrotransfer

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital Herlev	Herlev
France	Gustave Roussy Institute	Kremlin Bicetre
Slovenia	Institute of Oncology Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
Onxeo

Countries where clinical trial is conducted

Denmark,  France,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		9 weeks	No

External Links

•   Gene electrotransfer of plasmid antiangiogenic metargidin peptide (AMEP) in disseminated melanoma: safety and efficacy results of a phase I first-in-man study.