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Electrochemotherapy on Head and Neck Cancer

Primary Purpose

Head Neck Cancer

Status

Unknown status

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

Electrochemotherapy

Cliniporator

Bleomycin

About this trial

This is an interventional treatment trial for Head Neck Cancer focused on measuring Electrochemotherapy, head neck cancer, bleomycin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject age > 18 years.
Verified cancer of the head and neck area of any histology.
At least one tumour lesion should be accessible for electroporation.
Performance status WHO <= 2nd
Progressive and / or metastatic disease.
Expected survival of > 3 months.
Measurable disease is defined as at least one measurable lesion by RECIST 1.1.
A treatment-free interval of more than 4 weeks since chemotherapy or radiation therapy.
The participant should have been offered the current standard treatment. If there are no further standard treatment to offer or if the participant does not want to receive this, the participant may be included in the trial.
The participant should be able to understand the information for participants and be willing and able to comply with hospitalization in the treatment and the agreed follow-up visits and tests.
Platelets ≥ 50 billion / L, INR (international normalized ratio) > 1.5. Medical correction is permitted, e.g. correction using vitamin K.
Sexually active women who can become pregnant should use adequate contraception during this trial and 6 months after administration of bleomycin (pill, spiral, injection of prolonged progestin subdermal implantation, hormone-containing vaginal devices, transdermal patches).
Signed informed consent. -

Exclusion Criteria:

Participants should be excluded if they meet just one of the criteria stated below.

Symptomatic progression of the participants cancerous disease that requires another intervention.
Acute lung infection
Symptoms of lung function impairment. This triggers a lung function test (DLCO = diffusing capacity of the lungs for carbon monoxide), if moderate to severe the participant will be excluded.
Previous bleomycin treatment with cumulative dose more than 240,000 Units / m2.
History of severe allergic reactions associated with bleomycin.
Allergy to constituents of the planned anesthetic.
Coagulation disorder which can not be corrected.
Chronic renal dysfunction with creatinine> 150 micromoles / liter, will trigger a Cr-51-EDTA (Chromium-51-ethylenediamine tetra acetic acid) clearance. If this is too impaired, the participant is excluded.
Pregnancy or lactation.
While participation in other clinical trials involving experimental drugs or involved in a trial within 4 weeks prior to study drug administration.
Other disorders investigator finds incompatible with participation in the trial. -

Sites / Locations

Department of Otorhinolaryngology, Rigshospitalet, Copenhagen University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Electrochemotherapy

Arm Description

25 patients treated with electrochemotherapy

Outcomes

Primary Outcome Measures

Tumour response from PET/CT scans (Positron Emission Tomography - Computed Tomography)

Secondary Outcome Measures

Tumour response from MRI scans (Magnetic resonance imaging)

Tumour response from tissue samples

Still cancer activity or not

VAS score (Visual Analogue Scale)

Participant assessed

Quality of life

EORTC scores for head and neck (The European Organisation for Research and Treatment of Cancer)

CTCAE recordings (Common Terminology Criteria for Adverse Events)

side effects scored by CTCAE version 4.0

Full Information

NCT ID

NCT02549742

First Posted

September 6, 2015

Last Updated

January 17, 2017

Sponsor

Rigshospitalet, Denmark

Collaborators

Copenhagen University Hospital at Herlev

1. Study Identification

Unique Protocol Identification Number

NCT02549742

Brief Title

Electrochemotherapy on Head and Neck Cancer

Official Title

Electrochemotherapy on Head and Neck Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Unknown status

Study Start Date

February 2014 (undefined)

Primary Completion Date

September 2019 (Anticipated)

Study Completion Date

September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rigshospitalet, Denmark

Collaborators

Copenhagen University Hospital at Herlev

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A phase II clinical trial testing electrochemotherapy on mucosal recurrent head and neck cancer. Twenty-five patients will be treated. Primary outcome is tumour response on imaging. Secondary outcomes are response from tissue samples, VAS score, Quality of life evaluation and side effects to treatment.

Detailed Description

Electric pulses may be used to transiently permeabilise cell membranes, enabling passage of otherwise non-permeating molecules. This dramatically enhances the cytotoxic effect of certain chemotherapeutic agents, and is termed electrochemotherapy. Electrochemotherapy is now standardly used in the treatment of cutaneous metastases of various cancers in over 100 cancer centers around Europe. The intention of this trial is to investigate the possible use of electrochemotherapy in recurrent head and neck cancer as a palliative treatment. Surgery and radiotherapy, with the possible addition of chemotherapy, cures a large part of patients with head and neck cancer. However, in the event of recurrence curative options may be exhausted and the patient is referred for palliative chemotherapy. It is for this patient group, the investigators propose electrochemotherapy in a clinical trial. The electrochemotherapy is administered as a once-only treatment, with possible retreatment after eight weeks. Under general anesthesia, chemotherapy is administered intravenously, followed by application of electric pulses to the tumour area. Before treatment, the location and spread of the tumour is determined by imaging. The trial includes evaluation of response by MRI (magnetic resonance imaging) and PET/CT (Positron Emission Tomography - Computed Tomography) scans (base-line, 4 weeks, 8 weeks), tissue samples, as well as adverse events registration and questionnaires on quality of life. The planned study is a phase II clinical study, prospective, observational with up to 25 patients. Treatments will be performed in collaboration between the Department of Oncology, Copenhagen University Hospital Herlev, which has extensive experience in electrochemotherapy, and the Department of Ear Nose and Throat Surgery at Copenhagen University Hospital Rigshospitalet, that has the surgical expertise and set-up needed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head Neck Cancer

Keywords

Electrochemotherapy, head neck cancer, bleomycin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Electrochemotherapy

Arm Type

Experimental

Arm Description

25 patients treated with electrochemotherapy

Intervention Type

Procedure

Intervention Name(s)

Electrochemotherapy

Other Intervention Name(s)

electroporation with chemotherapy, eletropermeabilization with chemotherapy

Intervention Description

Electroporation by a device, Cliniporator, combined with chemotherapy, Bleomycin.

Intervention Type

Device

Intervention Name(s)

Cliniporator

Intervention Description

Electric pulses , duration 100 microseconds, about 400 V given at 5000 Hz.

Intervention Type

Drug

Intervention Name(s)

Bleomycin

Intervention Description

Administered intravenously or injected into the tumour before electroporation.

Primary Outcome Measure Information:

Title

Tumour response from PET/CT scans (Positron Emission Tomography - Computed Tomography)

Time Frame

8 weeks after treatment

Secondary Outcome Measure Information:

Title

Tumour response from MRI scans (Magnetic resonance imaging)

Time Frame

8 weeks after treatment

Title

Tumour response from tissue samples

Description

Still cancer activity or not

Time Frame

4 weeks after treatment

Title

VAS score (Visual Analogue Scale)

Description

Participant assessed

Time Frame

baseline, 4 weeks and 8 weeks after treatment

Title

Quality of life

Description

EORTC scores for head and neck (The European Organisation for Research and Treatment of Cancer)

Time Frame

baseline, 4 weeks and 8 weeks after treatment

Title

CTCAE recordings (Common Terminology Criteria for Adverse Events)

Description

side effects scored by CTCAE version 4.0

Time Frame

baseline, 4 weeks and 8 weeks after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject age > 18 years. Verified cancer of the head and neck area of any histology. At least one tumour lesion should be accessible for electroporation. Performance status WHO <= 2nd Progressive and / or metastatic disease. Expected survival of > 3 months. Measurable disease is defined as at least one measurable lesion by RECIST 1.1. A treatment-free interval of more than 4 weeks since chemotherapy or radiation therapy. The participant should have been offered the current standard treatment. If there are no further standard treatment to offer or if the participant does not want to receive this, the participant may be included in the trial. The participant should be able to understand the information for participants and be willing and able to comply with hospitalization in the treatment and the agreed follow-up visits and tests. Platelets ≥ 50 billion / L, INR (international normalized ratio) > 1.5. Medical correction is permitted, e.g. correction using vitamin K. Sexually active women who can become pregnant should use adequate contraception during this trial and 6 months after administration of bleomycin (pill, spiral, injection of prolonged progestin subdermal implantation, hormone-containing vaginal devices, transdermal patches). Signed informed consent. - Exclusion Criteria: Participants should be excluded if they meet just one of the criteria stated below. Symptomatic progression of the participants cancerous disease that requires another intervention. Acute lung infection Symptoms of lung function impairment. This triggers a lung function test (DLCO = diffusing capacity of the lungs for carbon monoxide), if moderate to severe the participant will be excluded. Previous bleomycin treatment with cumulative dose more than 240,000 Units / m2. History of severe allergic reactions associated with bleomycin. Allergy to constituents of the planned anesthetic. Coagulation disorder which can not be corrected. Chronic renal dysfunction with creatinine> 150 micromoles / liter, will trigger a Cr-51-EDTA (Chromium-51-ethylenediamine tetra acetic acid) clearance. If this is too impaired, the participant is excluded. Pregnancy or lactation. While participation in other clinical trials involving experimental drugs or involved in a trial within 4 weeks prior to study drug administration. Other disorders investigator finds incompatible with participation in the trial. -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christina C. Plaschke, MD

Phone

+45 29 25 92 45

caroline@dadlnet.dk

First Name & Middle Initial & Last Name or Official Title & Degree

Irene Wessel, MD

Phone

+45 35 45 83 22

irene.wessel.01@regionh.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julie Gehl, MD

Organizational Affiliation

Denmark: Herlev and Gentofte Hospital, University of Copenhagen

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Otorhinolaryngology, Rigshospitalet, Copenhagen University Hospital

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christina C. Plaschke, MD

Phone

+45 29 25 92 45

caroline@dadlnet.dk

First Name & Middle Initial & Last Name & Degree

Irene Wessel, MD

Phone

+45 35 45 83 22

irene.wessel.01@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Electrochemotherapy on Head and Neck Cancer

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