EUCTR2011-000661-12-GB进行中（未招募）不适用
A randomised double blind phase 2 trial of whole brain radiotherapy with or without vandetanib in metastatic melanoma with brain metastases - XRT +/- vandetanib in CNS melanoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 86
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •A patient will be eligible for inclusion in this study if all of the following criteria apply: 1. Age = 18 years. 2. Able to give written informed consent. 3. Histologically/cytologically proven malignant melanoma. 4. Unresectable stage III or IV metastatic melanoma with brain metastases. 5. Karnofsky performance score =70% (see appendix 1 of trial protocol). 6. RTOG RPA score 1 or 2 (see appendix 6 of trial protocol). 7. Measurable disease as defined by RECIST version 1.1. 8. Life expectancy of at least 12 weeks. 9. Haematological and biochemical indices within the ranges shown below: Haemoglobin (Hb) = 10 g/dL White Blood Count (WBC) = 3 x 109/L Platelet count = 100,000/µL Absolute Neutrophil Count (ANC) = 1.5 x 109/L Serum bilirubin = 1.5 x ULN AST or ALT = 2.5 x ULN ALP = 2.5 x ULN Creatinine clearance (Cockcroft-Gault) > 30 ml/min or Serum creatinine = 1.5 x ULN Serum potassium = LLN and < 5.5 mmol/L Serum magnesium = LLN and < 1.23 mmol/L Serum calcium = LLN and < 2.9 mmol/L 10. Adequate cardiac function (NHYA 0-1). 11. QTc <480 msec on screening ECG. 12. The patient is willing and able to comply with the protocol for the duration of the study, and scheduled follow-up visits and examinations.
- •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 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •A patient will not be eligible for the trial if any of the following apply: 1. Any radiotherapy or systemic melanoma therapy within 28 days prior to starting trial treatment, except palliative radiotherapy. 2. Prior whole brain irradiation. 3. CNS melanoma where all detectable disease has been treated by neurosurgery or stereotactic irradiation. 4. Presence of leptomeningeal disease. 5. More than 3 extra-cranial organ sites involved with melanoma. 6. Pregnant or breast-feeding women. Female patients must have a negative urinary or serum pregnancy test or have evidence of post-menopausal status (defined as absence of menstruation for >12 months, bilateral oophrectomy or hysterectomy). 7. Patients (both male and female) of reproductive potential who are not willing to use adequate contraceptive measures for the duration of the study (as detailed in the study protocol). 8. Clinically significant cardiovascular event (e.g. myocardial infarction, superior vena cava syndrome) within 3 months before study entry (defined as signing of consent form), heart failure (NYHA class 2 or above), presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia. 9. Uncontrolled hypertension (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg, despite treatment). 10. History of arrhythmia (multifocal premature ventricular contractions [PVCs], bigeminy, trigeminy, ventricular tachycardia or uncontrolled atrial fibrillation), which is symptomatic or requires treatment (CTCAE version 4.0 grade 3) or asymptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled on medication is not excluded. 11. History of QT prolongation with other medications that required discontinuation of that medication. 12. Congenital long QT syndrome, or 1st degree relative with unexplained sudden death under 40 years of age. 13. Presence of left bundle branch block (LBBB) on screening ECG. 14. Serum calcium, magnesium or potassium below the normal range despite supplementation. 15. Concomitant medications that are potent inducers of CYP3A4 function (see appendix 5 of protocol). 16. Concomitant medications with a known risk of prolonging the QT interval or inducing Torsades de Pointes (see appendix 4 of protocol). If the patient is on any such medications, they need to be stopped at least 14 days prior to day 1 dosing. If they cannot be stopped, the patient is excluded. 17. Ocular malignant melanoma. 18. Another active malignancy within the past five years, with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin. 19. Any clinically significant and uncontrolled major medical condition(s). 20. Any unresolved toxicity greater than CTCAE version 4.0 grade 1 from previous anti-cancer therapy. 21. Inability to swallow tablets, refractory nausea and vomiting, chronic gastrointestinal disease (eg: inflammatory bowel disease), significant bowel resection, or any other condition that would preclude adequate absorption of vandetanib. 22. Currently active diarrhoea that may affect the ability of the patient to absorb vandetanib or tolerate treatment-induced diarrhoea. 23. Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV. 24. Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy. 25. Other psychological, social
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