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

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.