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Trial record 1 of 1 for:    NCT01941901
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Calcium Electroporation for Treatment of Cutaneous Metastases

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ClinicalTrials.gov Identifier: NCT01941901
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Julie Gehl, Herlev Hospital

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients with cutanoues tumors of any cancer histology were included, and metastases were marked, numbered and photographed. Syringes with either calcium or bleomycin were prepared by a pharmacist, blinded for the treating clinician. After injection of study drug (calcium or bleomycin), electroporation was performed. Metastases were followed and at the 6 month follow-up response was recorded for treated metastases and the actual drug used for each metastasis was revealed.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The patient and treating doctor only knew the size of the treated tumor, and the injection volume, but not the content of the syringe (either calcium or bleomycin).
Primary Purpose: Treatment
Official Title: Calcium Electroporation for Treatment of Cutaneous Metastases
Study Start Date : September 2013
Actual Primary Completion Date : September 2016
Actual Study Completion Date : January 23, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arms and Interventions
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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
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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, Older Adult)
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
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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


Locations
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Denmark
Department of Oncology, Copenhagen University Hospital, Herlev
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Investigators
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Principal Investigator: Julie Gehl Department of Oncology, Copenhagen University hospital, Herlev
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Julie Gehl, Medical Doctor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01941901    
Other Study ID Numbers: AA1232
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019
Keywords provided by Julie Gehl, Herlev Hospital:
Cutaneous metastases
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Skin Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Skin Diseases
 Calcium, Dietary
Bleomycin
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Antibiotics, Antineoplastic
Antineoplastic Agents