Electrochemotherapy as a Palliative Treatment for Brain Metastases

NCT01322100 | Terminated Phase 1 DMC

• 1 other identifier: HJ 1020
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Brain Metastases; CNS Metastases

Keywords

Brain Metastases, CNS Metastases

Outcome Measures

Primary Outcomes (1)

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

  From treatment to last follow up, planned 6 months

Secondary Outcomes (1)

• Efficacy of the trial treatment. This is evaluated by target tumor response on Magnetic resonance imaging (MRI).

  Patients are evaluable 50 days after treatment

Interventions

The Electroporation System DEVICE

The Electroporation System comprises of 3 parts: 1.Switch Box, 2. Driver, 3. Brain Probe

Bleomycin DRUG

Bleomycin dosage for i.v. use is 15.000 IU/m2, and is administered 10-30 minutes before the electric pulses. Bleomycin dosage for intratumoral use is either 2.000 IU, 4.000 IU, or 6.000 IU per 3 ml, and 20 % of the calculated tumor volume is injected.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Copenhagen University Hospital at Herlev: lead
• Rigshospitalet, Denmark: collaborator
• Glostrup University Hospital, Copenhagen: collaborator

Study Sites (2)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Herlev Hospital

Herlev, 2730, Denmark

Location

Related Publications (2)

• Linnert M, Gehl J. Bleomycin treatment of brain tumors: an evaluation. Anticancer Drugs. 2009 Mar;20(3):157-64. doi: 10.1097/CAD.0b013e328325465e.

  PMID: 19396014 BACKGROUND

• Gothelf A, Mir LM, Gehl J. Electrochemotherapy: results of cancer treatment using enhanced delivery of bleomycin by electroporation. Cancer Treat Rev. 2003 Oct;29(5):371-87. doi: 10.1016/s0305-7372(03)00073-2.

  PMID: 12972356 BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Bleomycin

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Julie Gehl, MD, DMSci

  Department of Oncology, Herlev Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2011
• First Posted: March 24, 2011
• Study Start: April 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 31, 2013

Record last verified: 2013-07

Locations

DK (2)