Calcium Electroporation for Treatment of Cutaneous Metastases

NCT01941901 | Completed Phase 2 DMC

• 1 other identifier: AA1232
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Metastases

Keywords

Cutaneous metastases

Outcome Measures

Primary Outcomes (1)

• Tumor response

  Response evaluated by "Response Evaluation Criteria in Solid Tumors" (RECIST) guidelines version 1.1.

  After 6 months

Secondary Outcomes (1)

• Adverse events to calcium electroporation

  After 6 months

Other Outcomes (1)

• Compare tumor response of calcium electroporation with tumor response of electroporation. Response is evaluated by RECIST criteria.

  After 6 months

Study Arms (2)

Calcium electroporation

EXPERIMENTAL

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

Electrochemotherapy with bleomycin

ACTIVE COMPARATOR

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

Interventions

Calcium electroporation DRUG

Intratumoral injection, once only treatment.

Also known as: Calcium chloride., ATC code: A02AC, EV substance code SUB12664MIG

Calcium electroporation

Electrochemotherapy with bleomycin DRUG

Intratumoral injection, once only treatment

Also known as: ATC code L01DC01, EV substance code SUB00844MIG

Electrochemotherapy with bleomycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Department of Oncology, Copenhagen University Hospital, Herlev

Herlev, 2730, Denmark

Location

Related Publications (2)

• Falk H, Lambaa S, Johannesen HH, Wooler G, Venzo A, Gehl J. Electrochemotherapy and calcium electroporation inducing a systemic immune response with local and distant remission of tumors in a patient with malignant melanoma - a case report. Acta Oncol. 2017 Aug;56(8):1126-1131. doi: 10.1080/0284186X.2017.1290274. Epub 2017 Feb 22. No abstract available.

  PMID: 28562201 BACKGROUND

• Falk H, Matthiessen LW, Wooler G, Gehl J. Calcium electroporation for treatment of cutaneous metastases; a randomized double-blinded phase II study, comparing the effect of calcium electroporation with electrochemotherapy. Acta Oncol. 2018 Mar;57(3):311-319. doi: 10.1080/0284186X.2017.1355109. Epub 2017 Aug 17.

  PMID: 28816072 RESULT

MeSH Terms

Interventions

Calcium Chloride; Electrochemotherapy; Bleomycin

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Drug Therapy; Therapeutics; Electroporation Therapies; Electroporation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Julie Gehl

  Department of Oncology, Copenhagen University hospital, Herlev

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: 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.

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 13, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: January 23, 2017
• Last Updated: November 5, 2019

Record last verified: 2019-11

Locations

DK (1)