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. - Study investigating efficacy & safety of PC-A11 in head & neck cancer.

PCI Biotech AS0 个研究点目标入组 17 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

阶段: 2 期
状态: 招募中
发起方: PCI Biotech AS
入组人数: 17

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•To be eligible to participate in this study, patients must meet the following eligibility criteria
•1. Study eligibility reviewed and approved by interdisciplinary hospital team.
•2. Age >= 18 years.
•3. Histologically or cytologically confirmed diagnosis of recurrent SCCHN, with or without metastasis, considered unsuitable for surgery and radiotherapy (patients with distant or regional metastatic disease may be eligible if local palliation is needed).
•4. Performance status (ECOG <= 1).
•5. At least one measurable target lesion at baseline.
•6. Local disease including margins treatable with superficial and/or interstitial laser light application. For superficial lesions: entire tumour accessable for laser light application, treatment margin is 0.5 cm. For interstitial treatment: insertion of implants feasible, treatment margin is 1.0 cm
•7. Estimated life expectancy of at least 12 weeks.
•8. Written informed consent.

排除标准

•Prior Treatment;
•1. Local treatment (e.g. surgery or radiation) 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 (as defined by CTCAE version 4.0);
•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)
•14. Tumours known or suspected to be eroding into the dura mater or 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 for superficial tumours and 1.0 cm for interstitial tumours).
•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 on

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发起方

PCI Biotech AS

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