EUCTR2013-003133-14-PT进行中（未招募）1 期
An open-label study to investigate the tolerability, pharmacokinetics and anti-tumor effect following photodynamic therapy (PDT) with single-ascending doses of LUZ11 in patients with advanced head and neck cancer. - Not applicable
uzitin, S.A.0 个研究点目标入组 6 人开始时间: 2013年9月27日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Able and willing to give written informed consent and adhere to all requirements of the study.
- •2. Man or non-pregnant and non-breast feeding woman.
- •3. Age = 18 years.
- •4. Karnofsky performance status of 60% (60% = requiring some help, can take care of most personal requirements) or greater.
- •5. With histologically confirmed diagnosis of recurrent/refractory squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma not otherwise specified (NOS), etc.) of the head/neck.
- •6. Clearly visible tumour on the oral cavity or cutaneous surface and that is locally accessible for surface irradiation using a microlens optic fibre.
- •7. Head and neck squamous cell carcinoma (HNSCC) progressing after first line of palliative chemotherapy OR progressing = 6 months after radical chemoradiotherapy OR considered not suitable for standard anti-neoplastic treatment by a multidisciplinary team.
- •8. Absolute granulocyte count >1,500 cells/mL.
- •9. Platelet count >100,000 cells/mL.
- •10. Haemoglobin >9.0 g/dL (the use of transfusion or other intervention to achieve Hgb >9.0 g/dL is acceptable).
- •11. Total bilirubin < 2 times the upper limit of normal (ULN).
- •12. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times the ULN.
- •13. Serum creatinine < 2 times the ULN or creatinine clearance (CrCL) >50 mL/min determined by 24-h urine collection or estimated by Cockroff-Gault formula: CrCL male = [(140-age) x (weight in kg] /[(serum Cr mg/dL) x (72)]; CrCL female = 0.85 x (CrCL male).
- •14. If woman, she is not of childbearing potential or she agrees to use a medically effective means of birth control.
- •15. If man, he is not sexually active or he agrees to use a medically effective means of birth control.
- •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 3
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •1. Life expectancy less than 6 months.
- •2. Known hypersensitivity to porphyrins or any of the formulation ingredients.
- •3. History of severe hypersensitivity reactions to any drugs.
- •4. Porphyria or other diseases exacerbated by light.
- •5. Metastatic or locoregional progressive disease not amenable for complete treatment by PDT.
- •6. Tumours known to be eroding into a major blood vessel in or adjacent to the irradiation site.
- •7. Planned skin phototherapy session within the study timeframe.
- •8. Planned surgical procedure within the study timeframe.
- •9. Coexisting ophthalmic disease likely to require slit-lamp examination within the study timeframe.
- •10. Existing therapy with a photosensitising agent.
- •11. Unacceptable laboratory abnormalities.
- •12. Clinically relevant 12-lead ECG abnormalities.
- •13. Unstable angina and/or congestive heart failure requiring hospitalisation within 6 months prior to screening.
- •14. Myocardial infarction within 6 months prior to screening.
- •15. Cannot communicate reliably with the investigator.
- •16. Unlikely to co-operate with the requirements of the study.
- •17. Contra-indication to MRI with gadolinium (e.g., use of pacemaker, allergy to gadolinium).
- •18. Participation in a clinical trial within 2 months prior to screening.
- •19. If woman, she has a positive pregnancy test.
- •20. If woman, she is currently breast-feeding.
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