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

NCT00744653 | Terminated Phase 2 Results DMC

• 1 other identifier: H-B-2008-074
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Recurrence

Outcome Measures

Primary Outcomes (1)

• Clinical Measure of Lesion Size.

  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 Outcomes (2)

• Participants With Objective Response Evaluated With PET/CT

  3, weeks, 8 weeks, and up to 6 months after treatment

• Safety and Toxicity

  up to 1 year

Study Arms (1)

1

OTHER

Patients with local-regional recurrence of breast cancer, lesion over 3 cm.

Procedure: Electrochemotherapy

Interventions

Electrochemotherapy PROCEDURE

Electric pulses , duration 100 microseconds, about 400 V given at 5000 Hz. Drug used is Bleomycin.

Also known as: Device: Cliniporator, Drug: Bleomycin

1

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Copenhagen University Hospital at Herlev: lead

Study Sites (1)

Herlev Hospital, Herlev Ringvej 75

Herlev, DK-2730, Denmark

Location

Related Publications (1)

• Matthiessen LW, Johannesen HH, Hendel HW, Moss T, Kamby C, Gehl J. Electrochemotherapy for large cutaneous recurrence of breast cancer: a phase II clinical trial. Acta Oncol. 2012 Jul;51(6):713-21. doi: 10.3109/0284186X.2012.685524. Epub 2012 Jun 26.

  PMID: 22731832 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Recurrence

Interventions

Electrochemotherapy; Bleomycin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Electroporation Therapies; Electroporation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Early termination due to too few objective respondes using the primary endpoint.

Results Point of Contact

• Title: MD Louise Wichmann Matthiessen
• Organization: Copenhagen University Hospital Herlev

louise.wichmann.matthiessen@gmail.com

+ 45 38 68 98 58

Study Officials

• Julie Gehl, M.D.

  Department of Oncology, Copenhagen University Hospital at Herlev

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2008
• First Posted: September 1, 2008
• Study Start: October 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 18, 2014
• Results First Posted: July 18, 2014

Record last verified: 2014-06

Locations

DK (1)