Ulcerated Cutaneous MetastasesPhase 2NCT00918593
Palliative Treatment of Ulcerated Cutaneous Metastases: Trial Between Electrochemotherapy and Radiotherapy
A Phase 2 study testing Electrochemotherapy, Radiotherapy and Bleomycin in people with Ulcerated Cutaneous Metastases, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerated Cutaneous Metastases
- What is being tested?
- Electrochemotherapy, Radiotherapy and Bleomycin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2009to Feb 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen University Hospital at Herlev
Herlev, Copenhagen, 2730
About this study
Official title: Palliative Treatment of Ulcerated Cutaneous Metastases: Randomised Trial Between Electrochemotherapy and Radiotherapy
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.
Read the 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'.
- Conditions
- Ulcerated Cutaneous Metastases
- Being tested
- Electrochemotherapy, Radiotherapy, Bleomycin
- Keywords
- Metastases, Cutaneous, Ulcerating, Palliative, ulcerating metastases
- Medical subject headings
- Neoplasm Metastasis, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrochemotherapyDrug
Also called ECT
Intratumoral or intravenous bleomycin followed by electric pulses. Once only treatment.
RadiotherapyRadiation
Also called RT
Radiotherapy according to hospital procedures.
BleomycinDrug
Intratumoral or intravenous bleomycin followed by electric pulses. Once only treatment.
| Study group | Role | What they receive |
|---|---|---|
| Electrochemotherapy | Experimental | Not described Receives: Drug: Electrochemotherapy; Drug: Bleomycin |
| radiotherapy | Active comparator | Not described Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and response
Measured: 30 days
Secondary outcomes (2)
patient satisfaction
Measured: 180
Economics
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startDec 2009
- Primary completionAug 2013 (estimated)
- Study completionFeb 2014 (estimated)
Why it stopped: No recruitment of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerated Cutaneous MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie Gehl, Consultant, Principal investigator, Copenhagen University Hospital at Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918593
- Sponsor's protocol ID
- AA0906
- Other IDs
- EudraCT number: 2009-011455-51
- Status last verified
- Sep 2011
- First submitted
- 9 Jun 2009
- Last updated
- 27 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Treatment of Ulcerated Cutaneous Metastases: Randomised Trial Between Electrochemotherapy and Radiotherapy
- ClinicalTrials.gov ID
- NCT00918593
- Acronym / sponsor ID
- AA0906
- Conditions
- Ulcerated Cutaneous Metastases
- Keywords
- Metastases, Cutaneous, Ulcerating, Palliative, ulcerating metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No recruitment of patients
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 11 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrochemotherapy | Experimental | Drug: Electrochemotherapy, Drug: Bleomycin |
| radiotherapy | Active comparator | Radiation: Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectrochemotherapyAlso: ECTIntratumoral or intravenous bleomycin followed by electric pulses. Once only treatment. | Drug | Electrochemotherapy |
| RadiotherapyAlso: RTRadiotherapy according to hospital procedures. | Radiation | radiotherapy |
| BleomycinIntratumoral or intravenous bleomycin followed by electric pulses. Once only treatment. | Drug | Electrochemotherapy |
Primary outcome
Safety and response
Time frame: 30 days
2 secondary outcomes
patient satisfaction
Time frame: 180
Economics
Time frame: 180 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Gehl, Consultant principal investigator
Copenhagen University Hospital at Herlev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Electrochemotherapy, Radiotherapy and Bleomycin in people with Ulcerated Cutaneous Metastases, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and response (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2011.