Electrochemotherapy as a palliative treatment for brain metastases

• Conditions: Patient with brain metastases from cancer of any histology. A phase I trial.; MedDRA version: 12.1Level: LLTClassification code 10006128Term: Brain metastases

• Registration Number: EUCTR2010-023356-90-DK
• Lead Sponsor: Oncology Department

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-30
• Last Update Posted: 18 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1.Patients > 18 years.
2.ECOG performance status < 2.
3.Diagnosis of brain metastases originated from histological or cytological verified cancer of any histology.
4.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.
5.Patients must have been offered every available standard treatment. If there is no more standard treatment available or if a patient does not wish to receive the standard treatment, the patient can be included in this study.
6.Endocrine anti-cancer treatment may be continued if the patient can benefit from this treatment i.e. obtain or gain control of the cancer outside the brain.
7.Ongoing chemotherapy that has had no effect on the present brain metastases may be continued. However, no chemotherapy should be given 3 weeks prior to and 2 weeks after treatment with electrochemotherapy.
8.Patients can be initiated on chemotherapy during this study as long as the treatment has no documented effect on brain metastases.
9.Local surgery or radiotherapy of a palliative nature and with no documented effect on brain metastases can be performed during the study.
10.Brain metastases to be treated must be > 10 millimetre and < 27 millimetre.
11.Brain metastases to be treated must be accessible for treatment. This assessment is performed by a neurosurgeon using a MRI scan of the brain.
12.Patients may have more brain metastases than are being treated.
13.Estimated remaining life time must be more than 3 months.
14.Patients must have adequate organ functions:
oAdequate bone marrow reserve: Leucocytes (WBC) > 3.0 x 109/l, thrombocytes > 75 x 109/l, hemoglobin > 7 g/dl.
oHepatic: 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.
oRenal: if creatinin > 150 micromolar do a GFR examination (Chrom-EDTA). If Chrom-EDTA clearance is less than 48 ml/min, treatment cannot be offered
15.Patients must not have a blood pressure (BP) over 180 mm Hg systolic and 110 mm Hg diastolic. In the case of BP>180/110 mm Hg, this can be medically corrected, and the patient can be included, when the BP is below this threshold.
16.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).
17.Participating patients must be able to understand the patient information (‘Deltagerinformation’).
18.Participating patients must have signed a written informed consent and power of attorney prior to inclusion in this study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Acute lung infection.
2.Previous bleomycin treatment with more than 200.000 Units/m2.
3.Previous allergic reaction to bleomycin.
4.Allergy towards the sedation used.
5.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 ovarectomy) or be post-menopausal defined as the absence of menstruation.
6.Treatment with G-CSF (Granulocyte Colony Stimulating Factor) or other cytokines.
7.Lung diffusion capacity (DLCO) below normal. DLCO is to be performed in case of suspected (anamnestic or clinical) reduced lung function.
8.Physician’s assessment that meningeal carcinomatosis (leptomeningeal disease) is a likely cause of the patient’s symptoms.
9.Treatment with anticoagulants (marevan, marcumar, innohep). If the physician finds it safe to pause the administration of anticoagulants the patient can be included. This decision should be made using the Neurosurgery Department’s Guideline.
10.Allergic to nickel, chromium or cobalt.
11.Participation in another clinical study with an experimental drug up to 4 weeks prior to inclusion.
12.Illnesses, medical, social or physiological, that may affect the patient’s ability to understand the patient information and participate in the follow-up.
13.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.
14.Treatment with Immunosuppressant drugs such as methotrexat and cyclosporine during the study. Treatment with prednisolone is accepted during the study.
15.Implanted pacemaker, defibrillators or hearth valve prosthetics.
16.Implanted devices such as neurostimulators, eartransplants, insulinpump, metallic tracheostomy.
17.Catheters with metal such as Port á cath, Swan Ganz, P-dialysis cath., ventriculoartrial and -peritoenal shunts, bladder cath. with thermo measurement.
18.Metallic clips/prosthetics/magnets from surgery such as neuro- or abdominal clips, tooth- or other prosthetics.
19.Disorganised metallic material such as metal fragments in the eyes, shrapnel, gun shot injuries.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified