Antiviral therapy (cidofovir, an acyclic nucleoside phosphate) in combination with radiotherapy in HPV-positive tumours of the oropharynx: a phase 1 study. - Antrhox

Academisch Ziekenhuis Maastricht0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年6月11日

试验速览

暂无简介。

•·UICC TNM I-IV, for which curable (high dosing) radiotherapy is advised.
•·Histological proven HPV-positive oropharyngeal carcinoma in the dose escaltion schedule.
•·WHO performance status 0-4
•·Less then 10% weight loss the last 6 months
•·Normal serum bilirubin
•·Normal white blood cells, neutrophils, platelets, hemoglobin
•·No prior history of head or neck radiotherapy
•·No uncontrolled infectious disease
•·Willing and able to comply with the study prescriptions
•·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

•·Patients receiving agents with nephrotoxic potential. Such agents must be discontinued at least seven days prior to starting therapy with cidofovir.
•·Hypersensitivity to cidofovir
•·History of clinically severe hypersensitivity to probenecid or other sulfa-containing medications.
•·History of kidney function disorder.
•·Serum creatinine concentration >132,6 micromol/L, a calculated creatinine clearance /= 100mg/dL (equivalent to >/= 2+ proteinuria).
•·Recent (< 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction)
•·Pregnant women.
•·Age under 18 years.

发起方