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

NCT01664273 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2014-06-20

No results posted yet for this study

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).

Conditions

  • Metastatic Malignant Neoplasm

Interventions

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.

Sponsors & Collaborators

  • Copenhagen University Hospital at Herlev

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01664273 on ClinicalTrials.gov