Electrochemotherapy on Head and Neck Cancer

NCT02549742 | Unknown Phase 2 DMC

• 1 other identifier: HH1222
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Head Neck Cancer

Keywords

Electrochemotherapy; head neck cancer; bleomycin

Outcome Measures

Primary Outcomes (1)

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

  8 weeks after treatment

Secondary Outcomes (5)

• Tumour response from MRI scans (Magnetic resonance imaging)

  8 weeks after treatment

• Tumour response from tissue samples

  4 weeks after treatment

• VAS score (Visual Analogue Scale)

  baseline, 4 weeks and 8 weeks after treatment

• Quality of life

  baseline, 4 weeks and 8 weeks after treatment

• CTCAE recordings (Common Terminology Criteria for Adverse Events)

  baseline, 4 weeks and 8 weeks after treatment

Study Arms (1)

Electrochemotherapy

EXPERIMENTAL

25 patients treated with electrochemotherapy

Procedure: Electrochemotherapy; Device: Cliniporator; Drug: Bleomycin

Interventions

Electrochemotherapy PROCEDURE

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

Also known as: electroporation with chemotherapy, eletropermeabilization with chemotherapy

Electrochemotherapy

Cliniporator DEVICE

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

Electrochemotherapy

Bleomycin DRUG

Administered intravenously or injected into the tumour before electroporation.

Electrochemotherapy

Eligibility Criteria

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

You may qualify if:

• 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. -

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Copenhagen University Hospital at Herlev: collaborator

Study Sites (1)

Department of Otorhinolaryngology, Rigshospitalet, Copenhagen University Hospital

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Electrochemotherapy; Electroporation; Drug Therapy; Bleomycin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics; Electroporation Therapies; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Julie Gehl, MD

  Denmark: Herlev and Gentofte Hospital, University of Copenhagen

  STUDY CHAIR

Central Study Contacts

Christina C. Plaschke, MD

CONTACT

+45 29 25 92 45; caroline@dadlnet.dk

Irene Wessel, MD

CONTACT

+45 35 45 83 22; irene.wessel.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, ph.d., associate professor

Study Record Dates

• First Submitted: September 6, 2015
• First Posted: September 15, 2015
• Study Start: February 1, 2014
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

DK (1)