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

NCT01045915 | Terminated Phase 1 DMC

• 2 other identifiers: BA2009/15/012009-013042-88
• Study Type: interventional
• Target: 5
• Locations: 3 countries
• Sites: 3

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.

Conditions

Melanoma

Keywords

Stage IIIB, stage IIIC or stage IV melanoma; Progressive melanoma not responding to previous treatments

Outcome Measures

Primary Outcomes (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

  9 weeks

Study Arms (1)

Plasmid AMEP electrotransfer

EXPERIMENTAL

Biological: naked DNA coding for protein AMEP

Interventions

naked DNA coding for protein AMEP BIOLOGICAL

2 injections 1 week interval of 4 increasing doses of plasmid with electrotransfer

Also known as: electrotransfer, electroporation

Plasmid AMEP electrotransfer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients who can benefit from other melanoma treatments including surgery;
• Significant cardiac arrhythmias, electronic pacemakers, defibrillators, or any implanted electronic device;
• Recent (less than 6 months) acute vascular diseases (stroke, MI…);
• Advanced peripheral arterial diseases, venous ulcers, or scleroderma;
• History or treatment of seizures within the last 5 years;
• Clinically significant abnormality at pre-study full physical examination;
• Any clinically significant ECG abnormalities;
• Prior systemic therapy or any other antineoplastic treatments within the last 4 weeks, radiotherapy or surgery unrelated to the fields in question are allowed;
• Abnormal renal function (creatinine plasma level \> ULN);
• 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;
• Abnormal bone marrow function: haemoglobin \< 10g/dL, WBC \< 3.109 /L and/or platelet count \< 100.103 /L;
• Clinically significant abnormality in pre-study laboratory tests;
• Evidence of significant active infection (e.g., pneumonia, wound abscess, etc);

Sponsors & Collaborators

• Valerio Therapeutics: lead

Study Sites (3)

Copenhagen University Hospital Herlev

Herlev, 2730, Denmark

Location

Gustave Roussy Institute

Le Kremlin-Bicêtre, 94805, France

Location

Institute of Oncology Ljubljana

Ljubljana, SI-1000, Slovenia

Location

Related Links

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

MeSH Terms

Conditions

Melanoma

Interventions

Electroporation

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Officials

• ATTALI Pierre, MD

  BioAlliance Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2010
• First Posted: January 11, 2010
• Study Start: July 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: January 1, 2013
• Last Updated: September 11, 2015

Record last verified: 2012-05

Locations

FR (1); SL (1); DK (1)