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Gene Electrotransfer to Muscle With Plasmid AMEP in Patients With Disseminated Cancer

19. juni 2014 oppdatert av: Copenhagen University Hospital at Herlev
Gene transfer by electroporation (gene electrotransfer) uses short electric pulses to transiently permeabilise the cell membrane enabling passage of plasmid DNA into the cell cytosol. It is an efficient non-viral method for gene delivery to various tissues. In this phase I dose-escalating study, patients will be treated with intramuscular gene electrotransfer of plasmid AMEP. Plasmid AMEP encodes protein AMEP which bind to α5β1 og αvβ3 integrins. Primary end point of the trial is safety and secondary end points are efficacy, pharmacokinetics and evaluation of potential discomfort associated with the treatment procedure using VAS (Visual Analogue Scale).

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Cohorts of 3 patients will be treated with increasing doses of plasmid AMEP. Up to 12 patients will be treated.

Treatment procedure: Local anesthetic is applied to m. quadriceps femoris (thigh muscle) and the skin. An incision of the skin is performed followed by dissection until the muscle is exposed. The surgical procedure is performed by plastic surgeons.

Plasmid AMEP is injected intramuscularly and immediately followed by application of electric pulses via a needle electrode inserted into the muscle. A combination of one high voltage pulse (700V/cm, 100 µs) followed by one low voltage pulse (80 V/cm, 400 ms) will be applied. The wound is sutured and a dressing is applied. Treatment procedure is estimated to 30 minutes.

All patients are hospitalized for 24 hours after treatment for the purpose of evaluation of vital signs, physical examination, AE and SAE recording and pharmacokinetics sampling (blood and urine).

Blood biochemistry including LDH and CK is taken 24 hours post treatment. ECG will be taken before and after treatment. Patients score discomfort or pain from treated area using VAS.

Studietype

Intervensjonell

Registrering (Faktiske)

7

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Danmark
      • Herlev, Danmark, 2730
        • Depart. of Oncology, Copenhagen Universtiy Hospital Herlev

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Age > 18 years.
  • Performance status < 1 (ECOG).
  • Histologically confirmed malignant tumor (solid tumor) of any histology,
  • Metastatic disease. Patients with asymptomatic brain metastases are eligible.
  • Patient should have been offered standard treatment. Patient is eligible if no standard treatment is available or if the patient does not wish to receive standard treatment.
  • Life expectancy ≥ 3 months.
  • Measurable disease defined as at least one measurable lesion according to RECIST 1.1
  • Patient should have adequate organ function:
  • Adequate bone marrow function: Neutrophil count ≥ 1.0 x 109/l (≤ grade 2 CTCAE 4.0); Platelet count ≥ 75 x 109/l (< grade 2 CTCAE 4.0); Hemoglobin ≥ 6,0 mmol/l.
  • Liver: ALAT or ASAT < 3 ULN (< grade 2 CTCAE 4.0); Bilirubin ≤ 1,5 ULN (< grade 2 CTCAE 4.0); APTT within normal range; INR ≤ 1,2 (< grade 1 CTCAE 4.0)
  • Kidney: Plasma creatinin ≤ 1.5 ULN (< grade 2 CTCAE 4.0)
  • At least 4 weeks since any anti-cancer treatment.
  • Men and women of reproductive age must use effective contraception during the study and at least 6 months after administration of plasmid AMEP.
  • Patient should be able to understand the participant information and able to comply with protocol requirements and scheduled visits.
  • Signed informed consent.

Exclusion Criteria:

  • Allergy to the anaesthetic used.
  • Clinical signs of active infection.
  • Implanted pacemaker, defibrillator or any other implanted electronic device.
  • Participation in other clinical trials involving experimental drugs or participation in a clinical trial within 4 weeks before initiation of study treatment.
  • AMI (acute myocardial infarction), stroke or acute ischemic event within the last 6 months.
  • Severe atherosclerosis, significant cardiovascular disease (NYHA III or IV) or significant arrhythmias.
  • Systolic blood pressure above 180 mm Hg and/or diastolic blood pressure above 110 mm Hg. If BP >180/110 mm Hg medical correction is allowed and the patient can be included when BP < 180/110 mm Hg.
  • Pregnancy and lactation.
  • Clinically significant coagulopathy.
  • Treatment with anticoagulant drugs.
  • Other disorders which the investigator finds incompatible with participation in the study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Safety of the trial treatment
Tidsramme: From treatment to last follow up, planned 8 weeks.
Safety is evaluated by registration of adverse events (Adverse Events and Serious Adverse Events) using the CTCAE criteria version 4.0. Patients are seen in the out patient clinic once a week during the first month after treatment (at day 8, day 15, day 22, day 29) and 8 weeks after treatment. If no progression of the disease at 8 weeks, patients are seen at 12 weeks and then every three months until disease progression or death.
From treatment to last follow up, planned 8 weeks.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Efficacy of the trial treatment
Tidsramme: PET/CT scan 4 weeks, 8 weeks and 12 weeks after trial treatment.
PET/CT scan will be evaluated using RECIST 1.1 (CT) and PERCIST (PET)
PET/CT scan 4 weeks, 8 weeks and 12 weeks after trial treatment.
Pharmacokinetics
Tidsramme: Pre-dose, 2, 6 and 24 hours after dose, day 8, 15, 22, 29 and 8 weeks after treatment.
Measurements of plasma and urine plasmid AMEP concentrations. Measurements of plasma and urine protein AMEP concentrations
Pre-dose, 2, 6 and 24 hours after dose, day 8, 15, 22, 29 and 8 weeks after treatment.
Discomfort associated with the treatment procedure
Tidsramme: Scoring 'immediately after treatment', '30 min after treatment' '6 hours after treatment' and 'pain in the past 24 hours', and day 8.
The patient completes VAS (Visual Analogue Scale) scores pain related to the treatment area at abovementioned time points.
Scoring 'immediately after treatment', '30 min after treatment' '6 hours after treatment' and 'pain in the past 24 hours', and day 8.
Safety
Tidsramme: Day after treatment and 14 days after treatment
MR scan of treated region (thigh muscle) in order to assess potential intramuscular edema or hematoma
Day after treatment and 14 days after treatment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Copenhagen University Hospital at Herlev

Etterforskere

  • Hovedetterforsker: Julie Gehl, MD DMSci, Department of Oncology, Copenhagen University Hospital Herlev

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2012

Primær fullføring (Forventet)

1. mai 2015

Studiet fullført (Forventet)

1. mai 2015

Datoer for studieregistrering

Først innsendt

16. juli 2012

Først innsendt som oppfylte QC-kriteriene

10. august 2012

Først lagt ut (Anslag)

14. august 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

20. juni 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. juni 2014

Sist bekreftet

1. juni 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AA 1201

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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