ACTRN12621000802808招募中2 期
A pilot open label study of [177Lu]Lu-octretotate and temozolomide in the treatment of succinate dehydrogenase-associated locally advanced or metastatic pheochromocytoma and paraganglioma in adults.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Signed written informed consent
- •2.PPGL diagnosed histopathologically (after biopsy or tumor resection) or high suspicion on imaging and biochemistry
- •3.SDH mutation confirmed on genetic testing
- •4.Patient age 18 years or older.
- •5.Locally advanced (defined as local invasion to surrounding structures) or metastatic (defined as occurrence of a tumour at a site where neural crest cells are not usually found, such as in bones, lungs, and liver) PPGL
- •6.Somatostatin receptor (SSTR) uptake on a 68Ga- DOTATATE positron emission tomography (DOTATATE PET) scan higher than the background liver activity, defined as Krenning score 3 or 4
排除标准
- •1.Impaired haematological function defined by the following laboratory values:
- •Anaemia (Hb < 90 g/L)
- •White blood cell count < 2 x 10^9 / L
- •Neutropenia (neutrophil count < 1.5 x 10^9 / L)
- •Thrombocytopenia (platelet count < 100 x 10^9/L)
- •2.Impaired kidney function defined by the following laboratory value:
- •Glomerular filtration rate (GFR) < 40 ml/min/1.73m^2
- •3.Impaired hepatic function defined by the following laboratory values:
- •Total serum bilirubin greater than or equal to 75 micromoles/L or greater than or equal to 1.5 x upper limit normal (unless Gilbert’s syndrome)
- •Albuminemia < 25 g/L
- •Prothrombin ratio decreased < 70%
- •4.Active hepatitis B infection
- •5.Previous external beam radiotherapy involving more than 25% of the bone marrow
- •6.Severe uncontrolled heart failure defined as class III or IV in the New York Heart Association (NYHA) classification
- •7.Pregnancy
- •8.Breastfeeding
- •9.Unwilling to use reliable contraception or avoid pregnancy or avoid sperm donation during treatment and for a minimum of the following 6 months after the end of the treatment
- •10.Receiving an investigational medicinal product within 30 days of screening
研究者
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