NL-OMON34295已完成2 期
PHASE I-II STUDY OF GEMCITABINE AND VALPROIC ACID PLUS VALGANCICLOVIR IN PATIENTS WITH ADVANCED NASOPHARYNGEAL CARCINOMA - Cytolytic virus activation (CLVA) therapy for patients with advanced NPC
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patient has histological confirmed residual, recurrent or metastatic nasopharyngeal carcinoma that has failed conventional curative treatments and deemed incurable, or patient refuses further treatment with conventional methods because of associated morbidity/mortality or private reasons.
- •Confirmed EBV positive NPC
- •Measurable disease, according to RECIST criteria
- •WHO PS 0-2
- •Minimal acceptable safety laboratory values.
- •a. ANC of >= 1.5 × 109/L
- •b. Platelet count of >= 100 × 109/L
- •c. Haemoglobin level of >= 10 g/dL (>= 6.2 mmol/L) (prior transfusion is permitted)
- •d. Hepatic function as defined by serum bilirubin <= 1.25 times the upper limit of normal (ULN), ALT and AST <= 2.5 times the ULN.
- •e. Renal function as defined by serum creatinine <= 1.25 times ULN or creatinine clearance >= 50 m/min (by Cockcroft-Gault formula).
- •Age 18-70 years
- •Signed written informed consent before any study related activities are carried out
- •Expected adequacy of follow-up
排除标准
- •Active infection (infection requiring IV antibiotics), including active tuberculosis, and known and declared HIV.
- •Pregnancy (absence confirmed by serum or urine β-HCG test) or lactation period
- •Concurrent treatment with any other anti-cancer therapy.
- •Class 3-4 cardiac morbidity, as defined by the New York Heart association Criteria (e.g. uncontrolled or symptomatic congestive heart failure, myocardial infarction within six months prior to the start of study, uncontrolled or symptomatic angina) and any cardiac condition, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
- •Current active hepatic or biliary disease (with exception of Gilbert*s syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
- •Presence of severe and/or uncontrolled concurrent medical disease (e.g. uncontrolled diabetes mellitus, uncontrolled liver disease, including chronic viral hepatitis judged at risk of reactivation, uncontrolled active infection such as HIV infection, etc.)
- •Concomitant (or within 4 weeks before randomization) administration of any other experimental drug under investigation; chemotherapy or other anti-cancer therapy for the recurrence or metastatic disease; chemotherapy for initial treatment, i.e. chemoradiotherapy, is allowed.
- •Concurrent or previous malignancy of a different tumor type within five years of starting the study except for adequately treated non-melanoma skin cancer or cervical intraepithelial neoplasia
- •Legal incapacity
- •History of malabsorption syndrome or other disease that could significantly affect absorption of drugs
- •Systemic steroids within 2 weeks prior to study treatment
- •Myocardial infarction or cerebrovascular accident (CVA) within 6 months prior to study treatment
- •Patients who have known hypersensitivity to the study medication
研究者
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