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Calcium Electroporation for Treatment of Cutaneous Metastases

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ClinicalTrials.gov Identifier: NCT01941901
Recruitment Status : Recruiting
First Posted : September 13, 2013
Last Update Posted : August 31, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Cutaneous Metastases Drug: Calcium electroporation Drug: Electrochemotherapy with bleomycin Phase 2

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%.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Calcium Electroporation for Treatment of Cutaneous Metastases
Study Start Date : September 2013
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Tumor response [ Time Frame: After 6 months ]
    Response evaluated by "Response Evaluation Criteria in Solid Tumors" (RECIST) guidelines version 1.1.


Secondary Outcome Measures :
  1. Adverse events to calcium electroporation [ Time Frame: After 6 months ]
    Describe adverse events using Common Terminology for Adverse Events, version 4.0


Other Outcome Measures:
  1. Compare tumor response of calcium electroporation with tumor response of electroporation. Response is evaluated by RECIST criteria. [ Time Frame: After 6 months ]
    It is a non-inferiority study, and we accept a difference in response on 15%.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Julie Gehl, Medical Doctor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01941901     History of Changes
Other Study ID Numbers: AA1232
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: August 31, 2015
Last Verified: August 2015

Keywords provided by Julie Gehl, Herlev Hospital:
Cutaneous metastases

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