NCT01664273

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Copenhagen University Hospital at Herlev · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Metastatic Malignant Neoplasm

Interventions

Type	Name	Description
DRUG	Plasmid AMEP	Cohorts of 3 patients will received increasing doses of plasmid AMEP: 50 μg, 100 μg, 250 μg and 500 μg. Starting dose will be the lowest dose. Injection volume will remain constant at 200 μL. Once-only treatment and intra-individual dose escalation will therefore not occur.

Timeline

• Start date: 2012-07-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2012-08-14
• Last updated: 2014-06-20

Locations

1 site across 1 country: Denmark