Calcium electroporation for the treatment of cutaneous metastases.

Phase 1

• Conditions: Patients suffering from advanced cancer with cutaneous metastases.; MedDRA version: 17.0Level: LLTClassification code 10040892Term: Skin metastasesSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-005704-17-DK
• Lead Sponsor: Julie Gehl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-27
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Age > 18 years
2. Patients should understand participants information.
3. Histologically confirmed cutaneous metastases of any histology.
4. At least 1. cutaneous metastases, between 0,5 to 3 cm, available to electroporation.
5. Patient should have been offered standard treatment.
6. At least 2 weeks since chemotherapy or radiotherapy.
7. performance status < 2 (ECOG)
8. Life expectancy >3 months
9. platelet count >50 mia/l, INR<1,2
10. Men and women of reproductive age must use effective contraception during the study.
11. Signed informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1. previously treatment with bleomycin > 200.000 Units/m2
2. Allergy to bleomycin.
3. Clinically significant coagulopathy.
4. Pregnancy or lactation.
5. Participation in other clinical trial involving experimental drugs or participation in a clinical trial within 4 weeks before study treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified