Histopathologic Effect of Calcium Electroporation on Cancer in the Skin

NCT04259658 | Completed Phase 2

• 1 other identifier: REG-114-2019
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

In this phase II study we investigate the effect of calcium electroporation on cancer in the skin investigated by histopathology.

Conditions

Cancer

Keywords

calcium; electroporation; tumor infiltrating lymphocytes; cancer; metastases

Outcome Measures

Primary Outcomes (1)

• The effect of calcium electroporation on tumor infiltrating lymphocyte (TIL) population.

  The primary endpoint of this study is to evaluate differences in TIL population in tissue samples from treated cancer tumours two days after calcium electroporation treatment compared to before treatment (biopsy taken on the day of treatment before the calcium electroporation procedure). TIL content in biopsies will be evaluated by pathological examination and expressed as percent of cells.

  2 days

Secondary Outcomes (23)

• Changes in immune markers

  3 months

• Tumour inflammation signature (TIS)

  3 months

• Molecular subtype classification

  3 months

• Size of lesion

  3 months

• TIL population and tumour type

  3 months

Study Arms (1)

Calcium electroporation treatment

EXPERIMENTAL

Experimental treatment with calcium electroporation for cutaneous metastases.

Combination Product: Calcium electroporation

Interventions

Calcium electroporation COMBINATION_PRODUCT

Patients with cutaneous metastases will be treated with calcium electroporation.

Calcium electroporation treatment

Eligibility Criteria

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

You may qualify if:

• Trial subject must be able to understand the participant information.
• Histologically verified cutaneous or subcutaneous, primary or secondary cancer of any histology.
• The patient can undergo any simultaneous medical treatment (endocrine therapy, chemotherapy, immunotherapy etc.).
• The patient can undergo radiation therapy during the study period, provided that the treatment field does not involve the treated area.
• Performance status ECOG/WHO ≤2
• At least one cutaneous or subcutaneous tumour measuring at least 5 mm.
• Both men and women who are sexually active must use safe contraception (contraceptive coil, deposit injection of gestagen, subdermal implantation, hormonal vaginal ring or transdermal patch.)
• Signed informed consent.

You may not qualify if:

• Pregnancy or lactation
• Allergy to local anaesthesia

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Dept. of Clinical oncology and Palliative Care

Næstved, Denmark

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Julie Gehl, MD

  Zealand University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective phase II clinical study: Patients with cutaneous metastases will be recruited at the Department of Oncology, Zealand University Hospital (ZUH). One cohort of 24 patients with respectively disseminated breast cancer or other solid tumour malignancies, will be included. This will be a non-randomized trial. All patients will have been offered the standard of care and all available alternatives before entering the protocol. Calcium electroporation will not be compared to other means of treatment. All patients will be treated once and patients with over 3 metastases will be offered retreatment of some of their metastases. A maximum of 2 treatments per patient will be conducted with an interval of minimum 4 weeks. The patients will be followed with regular examinations for 3 months, starting from first treatment day.

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: February 6, 2020
• Study Start: April 20, 2020
• Primary Completion: October 19, 2022
• Study Completion: July 27, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)