An Open-label, Single Arm, Multi-centre, Phase II Study to Evaluate the Safety and Efficacy of PC-A11 With Superficial and Interstitial Laser Light Application in Patients With Recurrent Head and Neck Squamous Cell Carcinoma Unsuitable for Surgery and Radiotherapy
1. Study eligibility reviewed and approved by interdisciplinary hospital team.
2. Age minimum 18 years.
3. Histologically or cytological confirmed diagnosis of recurrent or metastatic SCCHN
considered unsuitable for surgery and radiotherapy (patients with distant or regional
metastatic disease may be eligible if local palliation is needed)
4. Performance status (WHO scale/ECOG) ≤ 1.
5. At least one measurable target lesion at baseline.
6. Local disease including margin (0.5 cm) treatable with superficial and/or
interstitial laser light application (for superficial lesions: entire tumour
assessable for laser light application/interstitial treatment: insertion of implants
7. Estimated life expectancy of at least 12 weeks.
8. Written informed consent.
1. Local treatment of their SCCHN by surgery within the previous 4 weeks or by radiation
within the previous 3 months.
2. Previous treatment with systemic chemotherapy for their SCCHN within the last 4 weeks
3. Previous treatment with Photodynamic Therapy within the last 6 months.
4. Prior treatment with bleomycin.
5. Prior treatment with PC-A11.
6. Toxicities incurred as a result of previous anticancer therapy (radiation therapy,
chemotherapy, or surgery) which did not resolve to ≤ grade 2.
7. Current or recent (within 30 days of first study treatment) treatment with another
investigational drug or participation in another investigational study.
8. Other concurrent anticancer therapies.
9. Treatment with a medicinal product with known or potential drug-drug interaction with
bleomycin or Amphinex.
Haematology, coagulation and biochemistry:
10. Inadequate bone marrow function:
Absolute Neutrophil Count (ANC): < 1.5 x 109/L, or platelet count <100 x 109/L or
haemoglobin < 6 mmol/L.
11. Inadequate liver function, defined as:
Serum (total) bilirubin > 2 x the Upper Limit of Normal (ULN) for the institution.
Aspartate Amino Transferase (ASAT) or Alanine Amino Transferase (ALAT) > 2.5 x ULN.
Alkaline phosphatase levels > 2.5 x ULN.
12. Glomerular filtration rate (GFR) < 60ml/min.
13. Clinical significant electrolyte abnormalities (Potassium, Magnesium, Phosphate that
is greater than CTCAE grade 3 for both low and high values)
14. Tumours known or suspected to be eroding into a major blood vessel, e.g. carotid
artery (interna and /or communis) in or adjacent to the illumination site (minimum
distance between tumour tissue and critical structure should be 0.5 cm).
15. Nasopharyngeal carcinoma.
16. Conditions contraindicated for bleomycin treatment (current lung infection, severely
impaired pulmonary function) excluded by lung function test (either formal lung
function test for patients able to undertake such assessment, or a suitable opinion
by an appropriately trained Respiratory / Anaesthetic Clinical Specialist).
17. Conditions that worsen when exposed to light (including porphyria).
18. Inability to undergo CT or MRI.
19. Pregnancy or lactation (female patients with childbearing potential). Serum pregnancy
test to be performed within 7 days prior to study PC-A11 treatment start, or within
14 days followed by a confirmatory urine pregnancy test within 7 days prior to study
20. For female patients of childbearing potential (defined as < 2 years after last
menstruation and not surgically sterile) and male patients who are not surgically
sterile or with female partners of childbearing potential: absence of highly
effective method of contraception resulting in a low failure rate (i.e. less than 1%
per year). These methods of contraception according to the note for guidance on
non-clinical safety studies for the conduct of human trials for pharmaceuticals
(CPMP/ICH/286/95, modification) include consistent and correct use of hormone
containing implants and injectables, combined oral contraceptives, hormone containing
intrauterine devices, surgical sterilization, sexual abstinence and vasectomy. Note:
Abstinence is only acceptable as true abstinence: when this is in line with the
preferred and usual lifestyle of the subject, periodic abstinence (e.g., calendar,
ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable
methods of contraception.
21. Planned surgery, endoscopic examination or dental treatment in first 30 days after
22. Co-existing ophthalmic disease likely to require slit-lamp examination within the
first 90 days after PC-A11 treatment.
23. Congestive heart failure NYHA Class III and IV. Cardiac arrhythmias (except for
atrioventricular block type I, Mobitz type II, and Wenckebach type) signs and
symptoms of relevant cardiovascular disease.
24. Known allergy or sensitivity to photosensitisers.
25. Ataxia telangiectasia
26. Concomitant malignant disease, with exception of adequately treated basal cell
carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, or in-situ
carcinoma of the uterine cervix.
27. Evidence of any other medical conditions (such as psychiatric illness, infectious
diseases, physical examination or laboratory findings) that may interfere with the
planned PC-A11 treatment, affect patient compliance or place the patient at high risk
from treatment-related complications.