Know Cancer

forgot password

Electrochemotherapy as a Palliative Treatment for Brain Metastases

Phase 1
18 Years
Open (Enrolling)
Brain Metastases, CNS Metastases

Thank you

Trial Information

Electrochemotherapy as a Palliative Treatment for Brain Metastases

Electrochemotherapy is a cancer treatment modality comprising of a combination of electrical
pulses delivered by electrodes and chemotherapy supplied either intravenously or
intratumorally. It is a quick and effective treatment for cutaneous metastases < 3 cm with a
complete response rate of 73 % after once-only treatment. The available electrode devices
have so far only been applicable for cutaneous tumors. An electrode has now been developed
in collaboration with a medico-technical company. An increasing number of cancer patients
suffer from metastases to the brain due to e.g. better control of the systemic peripheral
cancer disease. The prognosis for patients with brain metastases remains poor and research
into new treatments are needed in this field.

Up to 18 patients will be treated in a dose-escalating study of electrochemotherapy for
brain metastases. Primary endpoint of the clinical trial is safety and secondary endpoint is
efficacy. One brain metastasis is treated once-only with the electrode device guided
stereotactically through a burr hole using CT monitoring. The patient will be fully
anesthetized during the treatment procedure. Patients are followed up for 6 months with
regard to neurological function, Barthel Index, steroid use and adverse effects registration
(CTCAE). Tumor response will be evaluated by Magnetic Resonance imaging (MRI).

The first 6 patients will receive an intravenous dose of bleomycin 15.000 IE/m2 before
electric pulses. The following patients will receive an additional intratumoral injection of
bleomycin of increasing concentration. The electrical pulses will consist of a series of
high voltage pulses of 0.1 millisecond duration.

Inclusion Criteria:

- Patients > 18 years.

- Performance status < 2 (ECOG - Eastern Cooperative Oncology Group).

- Diagnosis of brain metastases originated from histological or cytological verified
cancer of any histology.

- Patients should have received whole-brain radiation therapy (WBRT) with a time
interval of at least 2 months from completion of WBRT until inclusion in this study.

- Patients must have been offered every available standard treatment.

- Brain metastases to be treated must have a diameter of at least 10 millimetres and no
more than 27 millimetres.

- Brain metastases to be treated must be accessible for treatment.

- Estimated life expectancy must be more than 3 months.

- Patients must have adequate organ functions:

Adequate bone marrow reserve: Leucocytes (WBC) > 3.0 x 109/l, thrombocytes > 75 x 109/l,
hemoglobin > 7 g/dl.

Hepatic: Alkaline phosphate, ALAT or ASAT and bilirubin must not be increased more than 2
times, pp > 40, APTT in normal range. Medical correction is allowed, e.g. correction of
low pp using vitamin K.

Renal: if creatinin > 150 micromolar do a GFR examination (Chrome-EDTA).

- Patients must not have a blood pressure (BP) over 180 mm Hg systolic and 110 mm Hg

- Sexually active men and women of childbearing potential must use adequate birth
control during this study and 6 month after the administration of bleomycin
(contraceptive pills, intrauterine devices, injection of prolonged gestagen,
subdermal implantation, hormonal vaginal devices, transdermal patches).

- Participating patients must be able to understand the patient information.

- Participating patients must have signed a written informed consent and power of
attorney prior to inclusion in this study.

Exclusion Criteria:

- Acute lung infection.

- Previous bleomycin treatment with more than 200.000 IU/m2.

- Previous allergic reaction to bleomycin.

- Allergy towards the sedation used.

- Pregnancy or breastfeeding. Pregnancy in fertile women is excluded by a measurement
of HCG in a blood sample. Sterile or infertile women are excluded from the
requirement to use anticonception. To be considered sterile or infertile, the patient
must have undergone surgical sterilization (vasectomy/bilateral tubectomy,
hysterectomy and bilateral ovariectomy) or be post-menopausal defined as the absence
of menstruation.

- Treatment with G-CSF (Granulocyte Colony Stimulating Factor) or other cytokines.

- Lung diffusion capacity (DLCO) below normal. DLCO is to be performed in case of
suspected (anamnestic or clinical) reduced lung function.

- Physician's assessment that meningeal carcinomatosis (leptomeningeal disease) is a
likely cause of the patient's symptoms.

- Treatment with anticoagulants (marevan, marcumar, innohep).

- Allergic to nickel, chrome or cobalt.

- Participation in another clinical study with an experimental drug up to 4 weeks prior
to inclusion.

- Illnesses, medical, social or physiological, that may affect the patient's ability to
understand the patient information and participate in the follow-up.

- Other serious systemic illnesses (i.e. active infection, abnormal EKG) that the
investigator finds may affect the patient's safety and/or ability to complete the

- Treatment with Immunosuppressant drugs such as methotrexate and cyclosporine during
the study. Treatment with prednisolone is accepted during the study.

- Implanted pacemaker, defibrillators or hearth valve prosthetics.

- Implanted devices such as neurostimulators, eartransplants, insulinpump, metallic

- Catheters with metal such as Port รก cath, Swan Ganz, P-dialysis cath.,
ventriculoatrial and -peritoneal shunts, bladder cath. with thermo-measurement.

- Metallic clips/prosthetics/magnets from surgery such as neuro- or abdominal clips,
tooth- or other prosthetics.

- Disorganised metallic material such as metal fragments in the eyes, shrapnel, gun
shot injuries.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of the trial treatment. This is evaluated by adverse events registrations (CTCAE).

Outcome Time Frame:

From treatment to last follow up, planned 6 months

Safety Issue:


Principal Investigator

Julie Gehl, MD, DMSci

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Oncology, Herlev Hospital


Denmark: Danish Medicines Agency

Study ID:

HJ 1020



Start Date:

April 2011

Completion Date:

February 2014

Related Keywords:

  • Brain Metastases
  • CNS Metastases
  • Brain Metastases, CNS Metastases
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Brain Neoplasms