Electrochemotherapy for Chest Wall Recurrence af Breast Cancer: Present Challenges and Future Prospects.

June 18, 2014 updated by: Copenhagen University Hospital at Herlev
By applying short electric pulses to cells, the cell membranes can become permeabilised (electroporation). This can be used augment the effect of chemotherapy, by providing direct access to the cell cytosol. For the drug bleomycin, the enhancement of effect is several hundred fold, enabling once-only treatment. We wish to offer electrochemotherapy to breast cancer patients suffering from chest wall recurrences that are ulcerated or painful and where other treatments have failed.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Electrochemotherapy for chest wall recurrence of breast cancer. MD, Ph.D. student, Louise Wichmann Matthiessen, has been employed in 2008 to perform this study. She plans to complete her training as specialist in clinical oncology subsequently, and will thus be able to follow up the work after completion of her Ph.D. The study aims at giving palliation to patients who are suffering from painful, ulcerated metastases to the chest wall in a situation where other treatments have failed.

Inclusion criteria: Chest wall recurrence of breast cancer; all other modalities have failed or patients does not wish to receive them (e.g. chemotherapy); symptomatic relief is needed; WHO performance status 0-2; normal coagulation parameters, normal kidney and renal function; written, informed consent. Lesions totalling over 3 cm in diameter. Patient recruitment: 28 patients are to be recruited.

Treatment: Patients will be treated in general anesthesia (inhaling max. 30 % oxygen), and a standard dose of bleomycin (15.000 IU/ m2) will be given intravenously. Electric pulses will be administered using a square wave electroporator (IGEA, Carpi, Italy). Needle and plate electrodes are used in order to treat the affected area efficiently. Eight pulses at a frequency of 5 kHz will be used for each application of the electrodes. In this way, a large area can be treated within a short time. Post treatment, the area will be covered by dry dressings, as are standardly used.

The patients will be seen at 2, 4, and 8 weeks post treatment, and re-treatment can be administered up to three times in case there are areas which have not been insufficiently treated in the first round. Lung function will be followed by measurement of DLCO (carbon monoxide diffusion capacity).

The patients will furthermore be followed up to 1 year after treatment in monthly intervals, and after 1 year on a yearly basis for up to 5 years.

Evaluation: Evaluation is performed by a) measurement of lesion extension and digital photography, b) development of a mapping system: Chest wall recurrences are frequently a confluent mass of tumor with varying depth. Precise mapping of treatment areas and effect is warranted. To this end, a system combining a fixed point (e.g. small ink tattoo, as used in radiotherapy planning) with novel imaging techniques using the 3D computer tomography (CT) planning system employed for radiotherapy, is envisaged. Furthermore, PET-Dual Time Point scanning combined with CT scanning is being investigated as treatment evaluation.

Safety: Safety will be reported both in terms of evaluation of adverse events and in terms of patient satisfaction determined by questionnaire, including the 'Derriford Appearance Questionaire'(18).

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark, DK-2730
        • Herlev Hospital, Herlev Ringvej 75

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18
  • Histological proven cancer of the breast.
  • Progressive and/or metastatic disease.
  • No further standard treatment for the patient available or the patient does not wish to receive the offered standard treatment.
  • If Endocrine therapy: Progression in cutaneous lesions.
  • If treatment with trastuzumab (Herceptin)can continue this treatment if there is no regression in cutaneous lesions.
  • At least 2 weeks since last chemotherapy, patients treated with Navelbine (Vinorelbine), Capecitabin (Xeloda) or weekly Paclitaxel (Taxol)can continue this treatment if there is no regression in cutaneous metastases.
  • Malignant cutaneous or subcutaneous lesion to be treated ≥ 3 cm.
  • WHO performance ≤ 2.
  • Life expectancy of at least 3 months.
  • Platelets ≥ 50 mia/l, pp ≥ 40, APTT in normal area. Medical correction is allowed.
  • Sexual active men and women must use safe anticonceptive during and up to 6 month after last treatment.
  • Written informed consent must be obtained according to the local Ethics committee requirements.

Exclusion Criteria:

  • Acute lung infection
  • Previous bleomycin treatment exceeding 200.000 Units/m2.
  • Known hypersensitivity to any of the components of the treatment.
  • Known hypersensitivity to any of the components used in the planned anesthesia.
  • Pregnant or lactating women. In fertile women this is ensured by measuring HCG in blood.
  • Treatment with granulocyte colony stimulating factor (G-CSF) or other cytokines.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Patients with local-regional recurrence of breast cancer, lesion over 3 cm.
Procedure: Electrochemotherapy
Electric pulses , duration 100 microseconds, about 400 V given at 5000 Hz. Drug used is Bleomycin.
Other Names:
  • Device: Cliniporator
  • Drug: Bleomycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Measure of Lesion Size.
Time Frame: up to one year
Response was evaluated clinical using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines and documented with digital photography. Number of patients with objective response evaluated with clinical measure of lesion size
up to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants With Objective Response Evaluated With PET/CT
Time Frame: 3, weeks, 8 weeks, and up to 6 months after treatment
Participants with objective response evaluated with PET/CT. Objective Response evaluated with CT and PET/CT.
3, weeks, 8 weeks, and up to 6 months after treatment
Safety and Toxicity
Time Frame: up to 1 year
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen University Hospital at Herlev

Investigators

  • Principal Investigator: Julie Gehl, M.D., Department of Oncology, Copenhagen University Hospital at Herlev

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

August 29, 2008

First Submitted That Met QC Criteria

August 29, 2008

First Posted (Estimate)

September 1, 2008

Study Record Updates

Last Update Posted (Estimate)

July 18, 2014

Last Update Submitted That Met QC Criteria

June 18, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-B-2008-074

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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