eoadjuvant IntraviTreal Ranibizumab treatment in high risk Ocular melanoma patients: A two stage single centre Phase II single arm study (NITRO Trial) - NITRO - Version 1

Royal Liverpool and Broadgreen University Hospitals Trust0 个研究点目标入组 7 人开始时间: 2011年9月8日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•1) Confirmed diagnosis of uveal melanoma requiring enucleation 2) Must have ultrasonographically documented measurable disease within 4 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) Performance Status =2 6) Previous or present vascular intraocular diseases not requiring use of antiangiogenic agents will be allowed 7) Laboratory results: ? Hb = 10g/dl ? Platelets = 100,000mm3 ? WCC = 3.0 x 109/L ? ANC = 1.0 x 109/L ? Bilirubin < twice normal, Alkaline Phosphatase < 5 x normal ? INR ‹ 2 ? Cr = 1.5 ULN 8) Normal blood pressure or controlled hypertension. 9) No recent major surgical procedures (laparotomy or thoracotomy) within 4weeks. 10) No thromboembolic event within 6 months 11) No known coagulopathy disorder. 12) Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. 13) Before patient registration, written informed consent must be given according to ICH/GCP, and national regulations.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 13
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 12

•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 Trust