Electrochemotherapy of Head and Neck Cancer

Phase 1

Conditions: 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 clinicaltrial.
MedDRA version: 16.0Level: LLTClassification code 10068476Term: ElectrochemotherapySystem Organ Class: 100000004865
Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

Registration Number: EUCTR2013-002723-42-DK

Lead Sponsor: Rigshospitalet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 29

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

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