Safety and Efficacy Study after intramuscular injection followed by electransfer of Plasmid AMEP in patients suffering from advanced or metastatic melanoma

• Conditions: Treatment of patients suffering from advanced or metastatic melanoma (stages III, IV); MedDRA version: 14.1Level: PTClassification code 10025671Term: Malignant melanoma stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10027480Term: Metastatic malignant melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10025670Term: Malignant melanoma stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-005538-20-SI
• Lead Sponsor: BioAlliance Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-24
• Last Update Posted: 18 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

1.Patient eligible for curative treatments and/or any palliative treatments with demonstrated efficacy, including current treatments for brain metastasis if applicable
2.Patient with history of any other cancer within five years before enrollment (except cured basal cell carcinoma or cervical cancer in situ)
3.Patient with inadequate organ function
4.Not medically controlled coagulation disorder
5.Patient with electronic pacemakers, defibrillators, or any implanted electronic device
6.Any cardiac dysrhythmia (> grade 2)
7.Recent (less than 6 months) acute vascular diseases
8.Arterial vascular disorders = grade 2
9.Serious, non-healed wound, ulcer or bone fracture
10.Significant traumatic injury within 28 days prior to study treatment start or anticipation of the need for major surgery during study treatment
11.Evidence of ongoing or active viral or bacterial infection 12.Patient with life expectancy less than 3 months
13.Prior systemic therapy or any other antineoplastic treatments within the last 4 weeks, including radiotherapy or surgery
14.Patients who had participated in another clinical trial in the last 30 days prior to enrolment in the present clinical trial
15.Man and woman of child-bearing age without effective contraception method during the study and for 3 months after the last administration of Plasmid AMEP

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified