Metastatic Malignant Neoplasm Clinical Trial
Official title:
Gene Electrotransfer to Muscle With Plasmid AMEP in Patients With Disseminated Cancer
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).
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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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