Palliative Treatment of Ulcerated Cutaneous Metastases: Trial Between Electrochemotherapy and Radiotherapy

• Status: Withdrawn
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

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. The investigators wish compare electrochemotherapy with radiotherapy when treating ulcerated cutaneous metastases up to 5 cm in diameter from any kind of histology.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Copenhagen University Hospital at Herlev
• Treatments: Bleomycin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.