Status:
WITHDRAWN
Palliative Treatment of Ulcerated Cutaneous Metastases: Trial Between Electrochemotherapy and Radiotherapy
Lead Sponsor:
Copenhagen University Hospital at Herlev
Conditions:
Ulcerated Cutaneous Metastases
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
About 5 % of all cancer patients experience cutaneous metastases. Ulcerating metastases can be of great psychological distress for the patients and may also be painful. Radiation therapy is standard t...
Eligibility Criteria
Inclusion
- Age ≥ 18.
- Histological proven cancer, any histology.
- Progressive and/or metastatic disease.
- One or more ulcerating cutaneous metastases.
- Patient in need of palliation of the ulcerating metastases.
- Lesion to be treated between 1 cm - 5 cm in diameter.
- Lesions to be treated must be either stationary or progressing during any concomitant chemotherapy.
- 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
- Previous electrochemotherapy or radiotherapy in the area to be treated
- 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 anaesthesia.
- 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.
- Creatinine measurements over 150 micromolar will require Crohm-EDTA clearance. Crohm-EDTA below 48 ml/minute
- Abnormal DLCO. If clinical history of or suspected reduced lung capacity, DLCO must be performed.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2014
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00918593
Start Date
December 1 2009
End Date
February 1 2014
Last Update
September 27 2011
Active Locations (1)
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1
Copenhagen University Hospital at Herlev
Herlev, Copenhagen, Denmark, 2730