eoadjuvant IntraviTreal Ranibizumab treatment in high-risk Ocular melanoma patients: a two-stage single-centre phase II single arm study (NITRO trial)

Royal Liverpool and Broadgreen University Hospitals NHS Trust (UK)0 个研究点目标入组 7 人开始时间: 2012年3月16日最近更新: 2022年11月7日

适应症

试验速览

2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31425478 results (added 07/11/2019)

•1. Confirmed diagnosis of uveal melanoma requiring enucleation
•2. Must have ultrasonographically documented measurable disease within 4 weeks of treatment according to the WHO criteria
•3. Prior treatments with chemotherapeutic or antiangiogenic agents for other malignancies are allowed after 6 months of discontinuation
•4. Age >=18 years
•5. Eastern Cooperative Oncology Group (ECOG) Performance Status = 2
•6. Platelets =100,000mm3
•7. White cell count (WCC) = 3.0 x 109/L
•8. Absolute neutrophil count (ANC) = 1.0 x 109/L
•9. Bilirubin < twice normal, Alkaline Phosphatase < 5 x normal
•10. International Normalized Ratio (INR) < 2
•11. Cr =1.5 ULN
•12. Normal blood pressure or controlled hypertension
•13. No recent major surgical procedures (laparotomy or thoracotomy) within 4weeks
•14. No thromboembolic event within 6 months
•15. No known coagulopathy disorder
•16. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and followup
•schedule; those conditions should be discussed with the patient before registration in the trial
•17. Before patient registration, written informed consent must be given according to ICH/GCP, and national regulations
•18. Previous or present vascular intraocular diseases not requiring use of antiangiogenic agents will be allowed
•19. Hb = 10g/dl

•1. Serious underlying medical condition according to the judgement of the Principal Investigator
•2. Pregnant or nursing patients
•3. Inability to provide adequate informed consent
•4. Hypersensitivity to the active substance or to any of the excipients
•5. Active or suspected ocular or periocular infections
•6. Active severe intraocular inflammation

发起方

Royal Liverpool and Broadgreen University Hospitals NHS Trust (UK)