Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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21 September 2015 |
Main ID: |
NCT01045915 |
Date of registration:
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08/01/2010 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Safety and Efficacy Study of Electrotransfer of Plasmid AMEP to Treat Advanced or Metastatic Melanoma
AMEP |
Scientific title:
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Safety and Efficacy of Intratumoural Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma: an Open Phase 1 Trial |
Date of first enrolment:
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July 2010 |
Target sample size:
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5 |
Recruitment status: |
Terminated |
URL:
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https://clinicaltrials.gov/show/NCT01045915 |
Study type:
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Interventional |
Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Denmark
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France
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Slovenia
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Contacts
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Name:
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ATTALI Pierre, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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BioAlliance Pharma |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Melanoma
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Intervention(s)
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Biological: naked DNA coding for protein AMEP
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Primary Outcome(s)
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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]
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Secondary ID(s)
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BA2009/15/01
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2009-013042-88
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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