Gene Electrotransfer to Muscle With Plasmid AMEP in Patients With Disseminated Cancer
18 Years
N/A
Both
Metastatic Malignant Neoplasm
Trial Information
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
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety of the trial treatment
Outcome Description:
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.
Outcome Time Frame:
From treatment to last follow up, planned 8 weeks.
Safety Issue:
Yes
Principal Investigator
Julie Gehl, MD DMSci
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Oncology, Copenhagen University Hospital Herlev
Authority:
Denmark: National Board of Health
Study ID:
AA 1201
NCT ID:
NCT01664273
Start Date:
July 2012
Completion Date:
May 2015
Related Keywords:
- Metastatic Malignant Neoplasm
- electroporation
- gen electrotransfer
- muscle
- plasmid AMEP
- Neoplasms
- Neoplasms, Second Primary
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