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

Sponsor

Copenhagen University Hospital at Herlev (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00918593

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Ulcerated Cutaneous Metastases	Drug: Electrochemotherapy Radiation: Radiotherapy Drug: Bleomycin	Phase 2

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 treatment for ulcerating metastases, but there are no reports of response rate.

With this study we wish to compare electrochemotherapy with radiotherapy when treating ulcerated cutaneous metastases up to 5 cm in diameter from any kind of histology.

Patient recruitment: 98 patients are to be recruited, the patients will be randomized between electrochemothreapy or radiotherapy. 49 patients will be treated in each arm.

Treatment: Patients will be treated in local or general anesthesia (inhaling max. 30 % oxygen) Bleomycin will be given either intratumoral or intravenous. 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 5000 Hz or 1 Hz 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 8, 30, 60, 90 and 180 days post treatment. Chest X ray will be taken before and after treatment for the patients receiving electrochemotherapy.

Evaluation: Evaluation is performed by measurement of lesion extension and digital photography using the RECIST criteria. The first 10 patients in each treatment arm will also be PET/CT-scanned before and one week after treatment.

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'.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

98 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2009

Anticipated Primary Completion Date :

Aug 1, 2013

Anticipated Study Completion Date :

Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Electrochemotherapy	Drug: Electrochemotherapy Intratumoral or intravenous bleomycin followed by electric pulses. Once only treatment. Other Names: ECT Drug: Bleomycin Intratumoral or intravenous bleomycin followed by electric pulses. Once only treatment.
Active Comparator: radiotherapy	Radiation: Radiotherapy Radiotherapy according to hospital procedures. Other Names: RT

Arm

Intervention/Treatment

Experimental: Electrochemotherapy

Drug: Electrochemotherapy

Intratumoral or intravenous bleomycin followed by electric pulses. Once only treatment.

Other Names:

ECT

Drug: Bleomycin

Intratumoral or intravenous bleomycin followed by electric pulses. Once only treatment.

Active Comparator: radiotherapy

Radiation: Radiotherapy

Radiotherapy according to hospital procedures.

Other Names:

Outcome Measures

Primary Outcome Measures

Safety and response [30 days]

Secondary Outcome Measures

patient satisfaction [180]
Economics [180 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.