Calcium Electroporation for the Treatment of Cutaneous Metastases

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Herlev Hospital
Sponsor:
Information provided by (Responsible Party):
Julie Gehl, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01941901
First received: September 3, 2013
Last updated: September 10, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to evaluate the effect of calcium electroporation on cutaneous metastases, and compare calcium electroporation with standard treatment: electrochemotherapy.


Condition Intervention Phase
Cutaneous Metastases
Drug: Calcium electroporation
Drug: Electrochemotherapy with bleomycin
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Tumor response [ Time Frame: After 6 months ] [ Designated as safety issue: No ]
    Response evaluated by "Response Evaluation Criteria in Solid Tumors" (RECIST) guidelines version 1.1.


Secondary Outcome Measures:
  • Adverse events to calcium electroporation [ Time Frame: After 6 months ] [ Designated as safety issue: No ]
    Describe adverse events using Common Terminology for Adverse Events, version 4.0


Other Outcome Measures:
  • Compare tumor response of calcium electroporation with tumor response of electroporation. Response is evaluated by RECIST criteria. [ Time Frame: After 6 months ] [ Designated as safety issue: No ]
    It is a non-inferiority study, and we accept a difference in response on 15%.


Estimated Enrollment: 15
Study Start Date: September 2013
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Calcium electroporation

The metastases will be treated with intratumoral injection of calcium chlorid followed by electrotransfer.

It is a once-only treatment. Calcium chlorid concentration: 9mg/ml. Total dose: 0,5ml/cm3 tumor volume.

Drug: Calcium electroporation
Intratumoral injection, once only treatment.
Other Names:
  • Calcium chloride.
  • ATC code: A02AC
  • EV substance code SUB12664MIG
Active Comparator: Electrochemotherapy with bleomycin

The metastases will be treated with intratumoral injection of bleomycin followed by electrotransfer.

It is a once only treatment. bleomycin concentration: 1000 IU/ml. Total dose: o,5 ml/cm3 tumor volume.

Drug: Electrochemotherapy with bleomycin
Intratumoral injection, once only treatment
Other Names:
  • ATC code L01DC01
  • EV substance code SUB00844MIG

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT01941901

Contacts
Contact: Julie Gehl 004538683868 julie.gehl@regionh.dk

Locations
Denmark
Department of Oncology, Copenhagen University Hospital, Herlev Recruiting
Herlev, Denmark, 2730
Contact: Julie Gehl    004538683868    julie.gehl@regionh.dk   
Principal Investigator: Julie Gehl         
Sponsors and Collaborators
Herlev Hospital
Investigators
Principal Investigator: Julie Gehl Department of Oncology, Copenhagen University hospital, Herlev
  More Information

No publications provided

Responsible Party: Julie Gehl, Medical Doctor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01941901     History of Changes
Other Study ID Numbers: AA1232
Study First Received: September 3, 2013
Last Updated: September 10, 2013
Health Authority: Denmark: Danish Health and Medicines Authority

Keywords provided by Herlev Hospital:
Cutaneous metastases

Additional relevant MeSH terms:
Calcium, Dietary
Neoplasm Metastasis
Skin Neoplasms
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Skin Diseases
Bleomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014