EUCTR2009-013052-76-FR进行中（未招募）不适用
A single-arm, phase II study of SU11248 (sunitinib) in patients with von Hippel-Lindau (VHL) disease. - VHLSUT
ARTIC (Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie)0 个研究点开始时间: 2009年11月26日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •1.Patients must have genetically or clinically confirmed VHL disease and have symptoms from VHL that are no longer controllable by conventional approaches.
- •2.Patients must have at least one of the following lesions :
- •Eye : retinal hemangioblastoma that can no longer be treated by laser therapy or cryotherapy and resulting in progressive loss of vision;
- •CNS : cerebellar, bulbar, spinal, or cerebellopontine angle haemangioblastoma or endolymphatic sac tumor causing neurological symptoms that are not amenable to further surgery, or have recurred after a first surgery;
- •Kidney: multiple or bilateral tumors not accessible to conservative surgery, or tumors having recurred after surgery and/or radiofrequency ablation or advanced/metastatic RCC;.
- •Pancreas: inextirpable or advanced neuroendocrine tumors.
- •3.Patients previously treated for VHL with surgery, chemotherapy or radiotherapy are considered eligible for this study under the condition that these treatments were completed more than 4 weeks prior starting the study treatment. Previously radiated lesions will be considered as target lesions only if they demonstrate unequivocal evidence of growth upon imagery.
- •4.Male or female, at least 18 year-old.
- •5.Performance status ECOG 0-2
- •6.Life expectancy ? 3 months
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Chemotherapy, radiotherapy, radiofrequency or surgery within 4 weeks prior to entering the study or not complete recovering from adverse events due to drugs administered more than 4 weeks earlier.
- •4.Previous treatment with sunitinib
- •5.NCI-CTCAE grade ? 3 hemorrhage within 4 weeks prior to study entry.
- •6.History of known or suspected brain metastases, spinal cord compression, carcinomatous meningitis, evidence of leptomeningeal disease (excepted leptomeningeal hemangioblastoma, according to the neurologist) on screening CT scan or MRI.
- •7.Any of the following within the 6 months prior to study drug administration: symptomatic congestive heart failure, myocardial infarction or coronary artery bypass, pulmonary embolism, ongoing severe or unstable angina pectoris, NCI-CTCAE grade ? 2 cardiac dysrhythmia, cerebrovascular accident or transient ischemic attack.
- •8.Hypertension >140/90 mmHg that cannot be controlled despite optimal antihypertensive therapy.
- •13.Pregnancy or breastfeeding. Patients must agree to use effective contraception during the study, including oral contraceptives, intrauterine devices, or being unable to procreate.
- •14.Any other malignancy within the last 3 years excepted basal cell carcinoma, in situ cervical carcinoma, squamous cell skin cancer, pT1/a bladder cancer with no evidence of recurrence during the last 12 months.
研究者
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