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AzTrials

Brain MetastasesPhase 1NCT01322100

Electrochemotherapy as a Palliative Treatment for Brain Metastases

A Phase 1 study testing The Electroporation System and Bleomycin in people with Brain Metastases and CNS Metastases, run by Copenhagen University Hospital at Herlev at 2 sites in Denmark.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Metastases, CNS Metastases
What is being tested?
The Electroporation System and Bleomycin
How many people
1 participants
Where
2 sitesDenmark
Study dates
Apr 2011to Jul 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Rigshospitalet

    Copenhagen, 2100

  • Herlev Hospital

    Herlev, 2730

Other trials in Denmark

About this study

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).

Read the detailed description

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.

Being tested
The Electroporation System, Bleomycin
Keywords
Brain Metastases, CNS Metastases
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Electroporation SystemDevice

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

  • BleomycinDrug

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: From treatment to last follow up, planned 6 months

Secondary outcomes (1)

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

    Measured: Patients are evaluable 50 days after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionJul 2013 (estimated)
  4. Study completionJul 2013

Why it stopped: Due to slow patient recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01322100
Sponsor's protocol ID
HJ 1020
Status last verified
Jul 2013
First submitted
23 Mar 2011
Last updated
31 Jul 2013
Results posted
No
Data monitoring committee
Yes

Publications

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

    PubMed 19396014

  • 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.

    PubMed 12972356

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing The Electroporation System and Bleomycin in people with Brain Metastases and CNS Metastases, run by Copenhagen University Hospital at Herlev at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Due to slow patient recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of the trial treatment. This is evaluated by adverse events registrations (CTCAE). (time frame: From treatment to last follow up, planned 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01322100, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2013.

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