Head and Neck Cancer. We would like to investigate the possible use of electrochemotherapy in recurrent head and neck cancer. 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 exchausted and the patient is referred for palliative chemotherapy. It is for this patient group, that we would like to propose electrochemotherapy in a clinical trial. MedDRA version:
Conditions
Interventions
Trade Name: Bleomycin
Pharmaceutical Form: Powder for concentrate for solution for injection/infusion
INN or Proposed INN: BLEOMYCIN SULFATE
CAS Number: 9041-93-4
Concentration unit: IU international
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically verified cancer of any type in the head and neck area. 2. Progressive and/or metastatic disease 3. Primary disease not eligible for surgery for patient’s general conditions or for the need of extensive surgery 4. Patients must have been offered standard treatments 5. Measurable lesions suitable for application of electric pulses 6. Age> 18 yrs 7. Performance status (Karnofsky = 70; WHO = 2) 8. Life expectancy> 3 months 9. Treatment free interval of at least 4 weeks after previously applied chemo- or radiotherapy to the target lesions 10. Patients must be mentally capable of understanding the information given and sign informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 29 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 29
Exclusion criteria
Exclusion criteria: 1. Other symptomatic lesions not under control 2. Lesions not suitable for electrochemotherapy (bony invasion, large vessels infiltration, etc.) 3. Acute lung infection 4. Symptoms of poor lung function necessitates DLCO and patient can not be treated if this is abnormal 5. Severe coagulation disorders not correctable 6. Previous allergic reactions to bleomycin 7. If cumulative dose of 240000 IU BLM/m2 was previously exceeded 8. Chronic renal dysfunction (creatinine > 150 µmol/L) 9. Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. We would like to investigate the possible use of electrochemotherapy in recurrent head and neck cancer. Surgery and radiotherapy cures a large part of patients with head and neck cancer. However, in the event of recurrence curative options may be exhausted. It is for this patient group, that we 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 (Bleomycin) is administered, followed by application of electric pulses to the tumor area. Before treatment, the location and spread of the tumor is determined by imaging. Main objective is evaluation of tumor response on PET/CT scans. ;Secondary Objective: The trial includes evaluation of response by MRI and PET/CT-scans, tissue samples, as well as adverse events registration and questionnaires on quality of life. We will compare the different modalities for evaluating the effect of electrochemotherapy; CT scan, MRI scan, PET scan, biopsies and a clinical photography. Resulting in a guideline for future response evaluation to electrochemotherapy in the head and neck area. An evaluation of the utility of electrochemotherapy in the head and neck area. Is it usable to apply the treatment on mucosal tumors in the mouth and pharynx? Is the treatment tolerable for the patients? This project shall visualize the response of electrochemotherapy in the treatment of head and neck cancer, and gather as many information’s regarding the patients wellbeing, the cellular response and image modality during the treatment. Thereby enabling us to construct a guideline for future treatment with electrochemotherapy in head and neck can | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are: • Evaluation of PET-response in the tumour before and after treatment. • Evaluation of cellular response before and after treatment. • Evaluation of how well MRI imaging visualises the treated tumour site. • Recording of side effects to the treatment. • Recording of pain score and consumption of analgesics. • Evaluation of quality of life through questionnaires before and after treatment. • Recording of total and progression free survival. ;Timepoint(s) of evaluation of this end point: Image modalities can be evaluated 4 weeks, 8 weeks, 4,8 and 12 months after treatment. Biopsies (cellular response) are performed during treatment, 7 and 35 days after treatment. The patient is examined, side effects, pain score, consumption of analgesics and "quality of life"-questionnaire are recorded in the first 3 days after treatment during hospitalization, and in outpatient visits 7, 14, 35 and 63 days after treatment and at 3, 4, 5, 6, 8, 10 and 12 months after treatment. Progression free and total survival will be followed during the year each patient is examined and afterwards the patients will be routinely examined once each year. | — |
Countries
Denmark
Contacts
Public ContactØre-Næse-Hals Kirurgisk Klinik
Rigshospitalet
Outcome results
None listed