A Study to Evaluate the Safety and Efficacy of PC-A11 in Patients With Recurrent Head and Neck Squamous Cell Carcinoma

• Status: Terminated
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of PC-A11 with superficial and/or interstitial laser light application in patients with recurrent SCCHN.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PCI Biotech AS
• Treatments: Bleomycin

Criteria

Inclusion Criteria:

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 feasible)

7. Estimated life expectancy of at least 12 weeks.

8. Written informed consent.

Exclusion criteria:

Prior Treatment:

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.

Current Treatment:

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) < 30ml/min.

13. Clinical significant electrolyte abnormalities (Potassium, Magnesium, Phosphate that is greater than CTCAE grade 3 for both low and high values)

Other:

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 treatment start.

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 PC-A11 treatment.

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.