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Calcium Electroporation for the Treatment of Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT03542214
Recruitment Status : Recruiting
First Posted : May 31, 2018
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Zealand University Hospital

Brief Summary:
In this phase I study 6 patients with inoperable colorectal cancer is treated with calcium electroporation to establish safety and efficacy of the treatment.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Stage IV Combination Product: Calcium electroporation Phase 1

Detailed Description:

A total of 6 evaluable patients with inoperable colorectal cancer are expected to be included in the study and the time for inclusion of patients is estimated to be 1-2 years. 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, but in case of residual tumor tissue at follow-up, and if the investigator considers it safe, they will be offered re-treatment. A maximum of 3 treatments per patient will be conducted with an interval of minimum 4 weeks. The patients will be followed with regular examinations for 12 months, starting from first treatment day.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Calcium Electroporation for the Treatment of Colorectal Cancer
Actual Study Start Date : April 24, 2018
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Calcium electroporation treatment
Experimental treatment with calcium electroporation for inoperabel colorectal cancer
Combination Product: Calcium electroporation
Patients with inoperable colorectal cancer will be treated with calcium electroporation




Primary Outcome Measures :
  1. Safety of the calcium electroporation procedure in colorectal cancer (registration of adverse events; CTCAE v4 will be used) [ Time Frame: 12 months ]
    Safety will be assessed through registration of adverse events related to the treatment. Furthermore, CT scans and follow-up endoscopies are performed as a safety marker to exclude any perforations, bleeding or infections. CTCAE v4 will be used.


Secondary Outcome Measures :
  1. Local response [ Time Frame: 18 months ]
    Tumor biopsies will be analyzed regarding standard histology and immunologic infiltration (CD8/CD3 and PD-L1/PD1)

  2. Systemic respons to calcium electroporation in colorectal cancer. [ Time Frame: 12 months ]
    Blood samples will be collected. Multiplex cytokine analyses and transcriptional analyses will be performed. Furthermore cell adhesion assay will be performed. Additionally circulating tumor DNA will be measured as a marker for the tumor burden

  3. Tumorregression [ Time Frame: 12 months ]
    CT/MR scans are performed and analyzed according to RECIST-criteria



Information from the National Library of Medicine

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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:

  • Histologically verified colorectal tumor
  • Conferred by multidisciplinary team (radiologists, surgeons and oncologists) discussing options possible for the patient, resulting in agreement that an endoscopic treatment with calcium electroporation should be offered to the patient.
  • Treatment free interval of minimum 2 weeks.
  • Thrombocytes ≥ 50 billions/l, INR >1,2. Medical correction is allowed, e.g. correction of elevated INR by means of vitamin K.
  • Performance status ECOG/WHO ≤2
  • 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.)
  • Trial subject ≥ 18 years.
  • Trial subject must be able to understand the participants' information.
  • Signed informed consent. The patients are considered participants in the study after signing of the informed consent.

Exclusion criteria:

  • Coagulative disturbance that cannot be corrected
  • Pregnancy or lactation (Pregnancy is ruled out in fertile women by an HCG test in a blood sample)
  • Concurrent participation in other clinical trials that involve experimental drugs or participation in a clinical trial involving experimental drugs within 4 weeks prior to administration of the drug in this study.
  • Treatment with bevacizumab within the last 4 weeks.
  • Heavily inflamed colorectal mucus membrane with bleeding or ulcerations.
  • Implanted colon stent
  • Other clinical disease or previous treatments that make the investigator deem the patient unfit.

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): NCT03542214


Contacts
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Contact: Malene Broholm Andersen, MD +45 41272742 malea@regionsjaelland.dk
Contact: Julie Gehl, DMSc kgeh@regionsjaelland.dk

Locations
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Denmark
Zealand University Hospital Recruiting
Roskilde, Denmark, 4000
Contact: Malene Broholm, cand.med.    41272742    malea@regionsjaelland.dk   
Sponsors and Collaborators
Zealand University Hospital
Investigators
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Principal Investigator: Julie Gehl, DMSc Zealand University Hospital

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Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT03542214     History of Changes
Other Study ID Numbers: HGH-2017-026
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Calcium
Calcium, Dietary
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents