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Calcium Electroporation for the Treatment of Cutaneous Metastases

Information source: Herlev Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cutaneous Metastases

Intervention: Calcium electroporation (Drug); Electrochemotherapy with bleomycin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Herlev Hospital

Official(s) and/or principal investigator(s):
Julie Gehl, Principal Investigator, Affiliation: Department of Oncology, Copenhagen University hospital, Herlev

Overall contact:
Julie Gehl, Phone: 004538683868, Email: julie.gehl@regionh.dk

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.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Tumor response

Secondary outcome: Adverse events to calcium electroporation

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%.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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.

Locations and Contacts

Julie Gehl, Phone: 004538683868, Email: julie.gehl@regionh.dk

Department of Oncology, Copenhagen University Hospital, Herlev, Herlev 2730, Denmark; Recruiting
Julie Gehl, Phone: 004538683868, Email: julie.gehl@regionh.dk
Julie Gehl, Principal Investigator
Additional Information

Starting date: September 2013
Last updated: September 10, 2013

Page last updated: August 20, 2015

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