Electrochemotherapy as a Palliative Treatment for Brain Metastases

• Status: Terminated
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Because electrochemotherapy is a quick and effective treatment for cutaneous metastases, a novel electrode device has been developed for treatment in soft tissue such as the brain. Up to 18 patients will be treated in this phase I 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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Copenhagen University Hospital at Herlev
• Collaborators: Glostrup University Hospital, Copenhagen; Rigshospitalet, Denmark
• Treatments: Bleomycin

Criteria

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 diastolic.

• 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 study.

• 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 tracheostomy.

• Catheters with metal such as Port á 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.