- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01764009
Safety and Efficacy of Intramuscular Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma (AIMM)
Safety and Efficacy of Intramuscular Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma: an Open-label Phase I/II Clinical Trial - The AIMM Study (AMEP In Metastatic Melanoma)
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
In this open-label, multicentre, dose escalation phase I study, successive cohorts of 3 patients suffering from advanced or metastatic melanoma will be electrotransferred increasing doses of Plasmid AMEP into muscle. Treatment will be repeated every 28 days until progression or limiting toxicity.
Consecutive cohorts of 3 to 6 patients will be treated with increasing doses of Plasmid AMEP at three dose levels: 0.25 mg, 1 mg and 4 mg according to an adapted 3+3 design. There will be no intra-patient dose escalation.
Undersøgelsestype
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Serious, non-healed wound, ulcer or bone fracture
- Significant traumatic injury within 28 days prior to study treatment start or anticipation of the need for major surgery during study treatment
- Evidence of ongoing or active viral or bacterial infection ( i.e bacterial infection requiring IV antibiotics)
- Patient with life expectancy less than 3 months
- Prior systemic therapy or any other antineoplastic treatments within the last 4 weeks, including radiotherapy or surgery
- Patients who had participated in another clinical trial in the last 30 days prior to enrolment in the present clinical trial
- 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 (i.e oral contraception or intra-uterine device for woman; i.e condom for man)
- Pregnant or nursing women
- Any significant disease, including psychiatric and neuromuscular disease, which may affect the proper evaluation of safety or efficacy or may affect ability to give informed consent
- Patients unwilling or unable to comply with protocol requirements and scheduled visits
- For contrast enhanced ultrasound (CEUS): known contraindications to SonoVue as described in the summary product characteristics (i.e cardiac or pulmonary history, hypersensitivity to sulphur hexafluoride or to any of the components of SonoVue)
- For the part II: prophylactic phenytoin in combination with dacarbazine.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Plasmid AMEP electrotransfer in muscle
|
injections 28days interval of 3 increasing doses of plasmid with electrotransfer
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Safety-Dose Limiting toxicity determination
Tidsramme: 8 weeks
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Safety- determination of the repeated dose
Tidsramme: 8 weeks
|
Main secondary endpoints will be safety parameters; the evaluation of efficacy parameters will allow identifying preliminary efficacy of Plasmid AMEP alone and determining the RP2D.
|
8 weeks
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
tolerability
Tidsramme: 8 weeks
|
|
8 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Bérangère VASSEUR, M.D., BioAlliance Pharma
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BA2011/15/02
- 2011-005538-20 (EudraCT nummer)
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Kliniske forsøg med Melanom
-
National Cancer Institute (NCI)ExelisisAfsluttetStage IV Uveal Melanoma AJCC v7 | Tilbagevendende uveal melanom | Stage III Uveal Melanoma AJCC v7 | Stage IIIA Uveal Melanoma AJCC v7 | Stadie IIIB Uveal Melanoma AJCC v7 | Stage IIIC Uveal Melanoma AJCC v7Forenede Stater, Canada
-
National Cancer Institute (NCI)AfsluttetFase IV kutan melanom AJCC v6 og v7 | Tilbagevendende melanom | Fase IIIC kutan melanom AJCC v7 | Slimhinde melanom | Iris melanom | Fase IIIA kutan melanom AJCC v7 | Fase IIIB kutan melanom AJCC v7 | Stage IV Uveal Melanoma AJCC v7 | Medium/Large Size Posterior Uveal Melanom | Tilbagevendende uveal melanom | Stage IIIA Uveal Melanoma AJCC v7 og andre forholdForenede Stater
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)AfsluttetFase IV kutan melanom AJCC v6 og v7 | Okulært melanom | Fase IIIC kutan melanom AJCC v7 | Kutant melanom | Slimhinde melanom | Fase IIIB kutan melanom AJCC v7 | Stage IV Uveal Melanoma AJCC v7 | Stadie IIIB Uveal Melanoma AJCC v7 | Stage IIIC Uveal Melanoma AJCC v7 | Stadie III Akral Lentiginøst Melanom AJCC... og andre forholdForenede Stater
-
Sidney Kimmel Cancer Center at Thomas Jefferson...PfizerAktiv, ikke rekrutterendeCiliær krop og choroid melanom, medium/stor størrelse | Ciliær krop og choroidea melanom, lille størrelse | Iris melanom | Stadium IIIA Intraokulært melanom | Stadium IIIB Intraokulært melanom | Stadie IIIC Intraokulært melanom | Stadie I Intraokulært melanom | Stadie IIA Intraokulært melanom | Stadie IIB... og andre forholdForenede Stater
-
National Cancer Institute (NCI)Memorial Sloan Kettering Cancer Center; Institut Curie Paris; Moffitt Cancer...Aktiv, ikke rekrutterendeMetastatisk uveal melanom | Stage IV Uveal Melanoma AJCC v7Forenede Stater
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)AfsluttetMetastatisk melanom | Fase IV kutan melanom AJCC v6 og v7 | Uoperabelt melanom | Slimhinde melanom | Stage IV Uveal Melanoma AJCC v7Forenede Stater
-
National Cancer Institute (NCI)AfsluttetStage IV Uveal Melanoma AJCC v7 | Tilbagevendende uveal melanomForenede Stater
-
National Cancer Institute (NCI)AfsluttetStage IV Uveal Melanoma AJCC v7 | Tilbagevendende uveal melanomForenede Stater, Frankrig, Det Forenede Kongerige
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeMetastatisk uveal melanom | Stage IV Uveal Melanoma AJCC v7Forenede Stater
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Bristol-Myers SquibbAktiv, ikke rekrutterendeMetastatisk uveal melanom | Metastatisk malign neoplasma i leveren | Stage IV Uveal Melanoma AJCC v7Forenede Stater
Kliniske forsøg med naked DNA coding for protein AMEP
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Shanghai 10th People's HospitalAnhui Medical University; The Affiliated Tumor Hospital of Nantong University...Ikke rekrutterer endnu
-
National Institute of Allergy and Infectious Diseases...University of Maryland, Baltimore; Duke University; HIV Vaccine Trials Network... og andre samarbejdspartnereTrukket tilbage
-
National Institute of Allergy and Infectious Diseases...Walter Reed Army Institute of Research (WRAIR); The Emmes Company, LLC; US... og andre samarbejdspartnereAktiv, ikke rekrutterende
-
National Institute of Allergy and Infectious Diseases...Afsluttet
-
Sohag UniversityRekrutteringSystemisk lupus erythematosusEgypten
-
National Institute of Allergy and Infectious Diseases...Novartis Vaccines; HIV Vaccine Trials Network; IPPOX FoundationAfsluttetHIV-infektionerSydafrika, Zambia, Tanzania
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeStadie IV analkræft AJCC v8 | Tilbagevendende cervikal karcinom | Metastatisk malign neoplasma | Stadie IV Peniskræft AJCC v8 | Tilbagevendende malign neoplasma | Ildfast malignt neoplasma | Stadie IV Livmoderhalskræft AJCC v8 | Stage IVA Livmoderhalskræft AJCC v8 | Stadie IVB Livmoderhalskræft AJCC v8 | Stage... og andre forholdForenede Stater
-
National Cancer Institute (NCI)RekrutteringStadie III Blære Urothelial Carcinoma AJCC v6 og v7 | Stadie IV Blære Urothelial Carcinoma AJCC v7 | Stadie II Blære Urothelial Carcinoma AJCC v6 og v7 | Muskelinvasiv blære Urothelial CarcinomForenede Stater
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Hospital for Special Surgery, New YorkChildren's Healthcare of Atlanta; Campbell Clinic; Pediatric Orthopaedic... og andre samarbejdspartnereRekrutteringSeptisk arthritis | Ledinfektion | Infektion af hofteled (lidelse) | Infektion af skulderledForenede Stater