Safety and Efficacy of Intramuscular Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma

NCT01764009 | Withdrawn Phase 1 DMC

• 2 other identifiers: BA2011/15/022011-005538-20
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 4

Brief Summary

The objective of the present trial is:

• to determine the dose limiting toxicity (DLT), maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of intramuscular electrotransferred Plasmid AMEP in patients with advanced or metastatic melanoma.
• to determine the local and general safety of intramuscular electrotransferred Plasmid AMEP
• to evaluate the efficacy of intramuscular electrotransferred Plasmid AMEP

Conditions

Melanoma

Keywords

Advanced Melanoma; Metastatic Melanoma; Melanoma Stage III and IV

Outcome Measures

Primary Outcomes (1)

• Safety-Dose Limiting toxicity determination

  Dose Limiting Toxicity (DLT) defined as any grade 4 clinical or biological event related to the study treatment and occurring during the first and second course (8 weeks) Safety parameters will be assessed according to the NCI-CTCAE v4.0 classification

  8 weeks

Secondary Outcomes (1)

• Safety- determination of the repeated dose

  8 weeks

Other Outcomes (1)

• tolerability

  8 weeks

Study Arms (1)

Plasmid AMEP electrotransfer in muscle

EXPERIMENTAL

Biological: naked DNA coding for protein AMEP

Interventions

naked DNA coding for protein AMEP BIOLOGICAL

injections 28days interval of 3 increasing doses of plasmid with electrotransfer

Also known as: electrotransfer, electroporation

Plasmid AMEP electrotransfer in muscle

Eligibility Criteria

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

You may qualify if:

• Aged over 18 years
• Patient with histologically or cytologically confirmed melanoma
• Patient with unresectable advanced or metastatic (stage III or IV) melanoma
• Patient with progressive melanoma (any BRAF status is permitted) not responding or intolerant to previous treatments, including patients with asymptomatic and not rapidly progressive brain metastases.
• Patient with a minimum of one measurable lesion according to RECIST guideline 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
• Patient having given a written informed consent

You may not qualify if:

• Patient eligible for curative treatments and/or any palliative treatments with demonstrated efficacy, including current treatments for brain metastasis, and including available BRAF inhibitors as indicated for patients carrying B-RAF mutated tumours if applicable.
• Patient with history of any other cancer within five years before enrollment (except cured basal cell carcinoma or cervical cancer in situ)
• Patient with inadequate organ function, defined as:
• Platelet count \< 75.103 /L (\> grade 2 NCI CTCAE)
• Absolute neutrophil count \< 1.109 /L (\> grade 2)
• Hemoglobin \< 9 g/dL
• INR increased or prolonged activated partial thromboplastin time (aPTT) upper the limit of normal (ULN) (≥ grade 1)
• Creatinine clearance \< 60 mL/min (Cockcroft and Gault formula) (≥ grade 2)
• Patient with ALT \> 3 ULN (≥ grade 2) or patient with symptomatic liver metastasis with ALT \> 5 ULN (\> grade 2)
• Serum Total Bilirubin \> 1.5 ULN (≥ grade 2); Patient with Gilbert's syndrome could be included if hyperbilirubinemia ≤ 3 ULN
• Not medically controlled coagulation disorder (i.e hemophilia, protein C or S deficiency…)
• Patient with electronic pacemakers, defibrillators, or any implanted electronic device
• Any cardiac dysrhythmia (\> grade 2) (i.e significant ventricular arrhythmia as persistent ventricular tachycardia and/or ventricular fibrillation; severe conduction disorders as atrio-ventricular block 2 and 3, sino-atrial block)
• Recent (less than 6 months) acute vascular diseases (i.e stroke, myocardial infarction)
• Arterial vascular disorders ≥ grade 2

Sponsors & Collaborators

• Valerio Therapeutics: lead

Study Sites (4)

Gustave Roussy Institute,

Le Kremlin-Bicêtre, 94805, France

Location

Hôpital Saint Louis. Service de dermatologie

Paris, 75010, France

Location

CHU Nancy Hôpital Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Institute of Oncology Ljubljana

Ljubljana, SI-1000, Slovenia

Location

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

• Bérangère VASSEUR, M.D.

  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 7, 2013
• First Posted: January 9, 2013
• Study Start: June 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: September 11, 2015

Record last verified: 2015-09

Locations

FR (3); SL (1)