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

This study has been withdrawn prior to enrollment.
(No recruitment of patients)
Sponsor:
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT00918593
First received: June 9, 2009
Last updated: September 26, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Ulcerated Cutaneous Metastases
Drug: Electrochemotherapy
Radiation: Radiotherapy
Drug: Bleomycin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Palliative Treatment of Ulcerated Cutaneous Metastases: Randomised Trial Between Electrochemotherapy and Radiotherapy

Resource links provided by NLM:


Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • Safety and response [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • patient satisfaction [ Time Frame: 180 ] [ Designated as safety issue: Yes ]
  • Economics [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 98
Study Start Date: December 2009
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Electrochemotherapy Drug: Electrochemotherapy
Intratumoral or intravenous bleomycin followed by electric pulses. Once only treatment.
Other Name: 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 Name: RT

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'.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00918593

Locations
Denmark
Copenhagen University Hospital at Herlev
Herlev, Copenhagen, Denmark, 2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Investigators
Principal Investigator: Julie Gehl, Consultant Copenhagen University Hospital at Herlev
  More Information

No publications provided

Responsible Party: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT00918593     History of Changes
Other Study ID Numbers: AA0906, EudraCT number: 2009-011455-51
Study First Received: June 9, 2009
Last Updated: September 26, 2011
Health Authority: Denmark: Ethics Committee and the Danish Medicines Agency

Keywords provided by Copenhagen University Hospital at Herlev:
Metastases
Cutaneous
Ulcerating
Palliative
ulcerating metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Ulcer
Skin Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Skin Diseases
Bleomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014