Calcium Electroporation for the Treatment of Cutaneous Metastases
Conditions
Cutaneous Metastases
Conditions: official terms
Neoplasm Metastasis - Skin Neoplasms
Conditions: Keywords
Cutaneous metastases
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: Calcium electroporation Type: Drug
Name: Electrochemotherapy with bleomycin Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to evaluate the effect of calcium electroporation on cutaneous metastases, and compare calcium electroporation with standard treatment: electrochemotherapy.
Detailed Description
Double-blinded phase II clinical study. We will compare the effect of calcium electroporation for the treatment of cutaneous metastases with standard treatment: electrochemotherapy with intratumoral injection of bleomycin. Separate randomisation will be performed and the lesions will be treated with either intratumoral injection of calcium or bleomycin. It is a once only treatment and the patients will be followed up for 6 months.

It is a non-inferiority study and we accept a difference in response on 15%.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Age > 18 years.

- Histological confirmed cutaneous metastases of any histology.

- At least 1. cutaneous metastases between 0,5 to 3cm, available to electroporation.

- Patient should have been offered standard treatment.

- At least 2 weeks since chemotherapy or radiotherapy.

- Performance status >2 (ECOG).

- Life expectancy >3 months.

- platelet count > 50 mia/l.

- International Normalized Ratio (INR) <1,2.

- Men and women of reproductive age must use effective contraception during the study.

- Patient should be able to understand participants information.

- Signed, informed consent.

Exclusion Criteria:

- Previously treatment with bleomycin > 200.000 Units/m2.

- Allergy to bleomycin.

- Clinically significant coagulopathy.

- Pregnancy or lactation.

- Participation in other clinical trial involving experimental drugs or participation in a clinical trial within 4 weeks before study treatment.
Location
Department of Oncology, Copenhagen University Hospital, Herlev
Herlev, Denmark
Status: Recruiting
Contact: Julie Gehl - 004538683868 - julie.gehl@regionh.dk
Start Date
September 2013
Sponsors
Herlev Hospital
Source
Herlev Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page