A pilot open label study of combination treatment lutate and temozolomide in the treatment of succinate dehydrogenase-associated pheochromocytoma and paraganglioma in adults.
- Conditions
- CancerCancer - Neuroendocrine tumour (NET)
- Registration Number
- ACTRN12621000802808
- Lead Sponsor
- Royal North Shore Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 4
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method