Status:
TERMINATED
Electrochemotherapy for Chest Wall Recurrence af Breast Cancer: Present Challenges and Future Prospects.
Lead Sponsor:
Copenhagen University Hospital at Herlev
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 c...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00744653
Start Date
October 1 2008
End Date
December 1 2010
Last Update
July 18 2014
Active Locations (1)
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1
Herlev Hospital, Herlev Ringvej 75
Herlev, Denmark, DK-2730