Gene Electrotransfer to Muscle With Plasmid AMEP in Patients With Disseminated Cancer
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
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
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
Safety of the trial treatment
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.
Julie Gehl, MD DMSci
Department of Oncology, Copenhagen University Hospital Herlev
Denmark: National Board of Health