NCT01266070终止2 期
A Pilot Trial of TKI 258 (Dovitinib) in Von Hippel-Lindau Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Most Frequent & Most Serious Adverse Events: Safety of Dovitinib for 6 Months
研究概览
简要总结
The goal of this clinical research study is to learn if dovitinib can safely be given to patients who have VHL with a measurable hemangioblastoma (tumor of the central nervous system). The effects of this drug on the disease will also be studied.
详细描述
The Study Drug:
Dovitinib is designed to perform several anti-tumor functions, including cutting off the blood supply to tumors.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take 5 dovitinib capsules by mouth each day on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle.
You should take the dovitinib capsules with about a cup (8 ounces) of water and at least 1 hour before breakfast or at least 2 hours following breakfast.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have genetically confirmed Von Hippel-Lindau (VHL) disease or patients with a clinical diagnosis of VHL.
- •At least one of the following measurable hemangioblastomas which is undergoing surveillance and the patient is not at immediate risk of needing intervention for this or other lesions. a.) Brain: asymptomatic hemangioblastoma, > 0.5 cm; b.) Spine: asymptomatic hemangioblastoma, > 0.5 cm; c.) Renal: solid mass suspicious for RCC >/=1 cm or cystic mass >/=1 cm; d.) Pancreas: solid mass >/=1cm and < 3 cm suspicious for neuroendocrine tumor; e.) Eye: asymptomatic peripapillary and/or macular hemangioblastoma, any size f. Adrenal: Pheochromocytoma greater than 1cm in size. NOTE: Biopsy is not required given the known natural history in the setting of a positive genetic test.
- •Allowable prior therapy: a.) Patients having undergone prior therapy for VHL lesions may enroll as long as other criteria are met. Previously radiated lesions may not be considered as target lesions unless they demonstrate unequivocal evidence of growth; b.) Major surgery, chemotherapy or radiation therapy completed > 4 weeks prior to starting the study treatment.
- •Age >/= 18 years. Because no dosing or adverse event data are currently available on the use of dovitinib in patients < 18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable
- •ECOG performance status </= 2
- •Patients must have normal organ and marrow function as defined below: a.) Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) </=2.5 x local laboratory upper limit of normal (ULN) are due to underlying malignancy; b.) Total serum bilirubin </=1.5 x ULN; c.) Absolute neutrophil count (ANC) >/= 1500/mcL; d.) Platelets >/=100,000/mcL; e.) Hemoglobin >/= 9.0 g/dL; f.) Serum creatinine < 1.5 x ULN; g) WBC >/= 3,000/mcl
- •Males (that have not been sterilized) and females of childbearing potential (female that has not be amenorrheic for at least 1 year or that has not surgically sterilized) must agree to use double-barrier birth control or abstinence while on the protocol treatment
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients who have had chemotherapy or radiotherapy within 4 weeks prior to starting study treatment or those who have not recovered (</= Grade 1 )from adverse events due to agents administered more than 4 weeks earlier.
- •Patients may not be receiving any other investigational agents.
- •Patients with any metastatic disease of any kind.
- •NCI CTCAE grade 3 hemorrhage within 4 weeks of starting the study treatment.
- •Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
- •Ongoing cardiac dysrhythmias of NCI CTCAE grade >/=
- •Prolonged QTc interval on baseline EKG > 470ms.
- •Hypertension that cannot be controlled by medications (>140/90 mm Hg despite optimal medical therapy).
- •LVEF assessed by 2-D echocardiogram (ECHO) < 50% or lower limit of normal (whichever is higher) or multiple gated acquisition scan ( MUGA) < 45% or lower limit of normal (whichever is higher).
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant women are excluded from this study because dovitinib has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with dovitinib, breastfeeding should be discontinued if the mother is treated with dovitinib.
- •Known HIV-positive patients taking combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with dovitinib. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
- •Women of child-bearing potential, who are biologically able to conceive, not employing two forms of highly effective contraception. Highly effective contraception (e.g. male condom with spermicide, diaphragm with spermicide, intra-uterine device) must be used by both sexes during the study and must be continued for 8 weeks after the end of study treatment. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (e.g., who has had menses any time in the preceding 12 consecutive months), must have a negative serum pregnancy test </= 14 days prior to starting study treatment.
研究组 & 干预措施
Dovitinib
Experimental
500 mg/day on a 5 day on, 2 day off schedule
干预措施: Dovitinib (Drug)
结局指标
主要结局
Most Frequent & Most Serious Adverse Events: Safety of Dovitinib for 6 Months
时间窗: Every 2 cycles (approximately 8 weeks) for 6 months
Most frequent \& Most Serious Adverse Events: Safety of treatment with Dovitinib for 6 months in participants with VHL who have a measurable hemangioblastoma undergoing surveillance evaluated by toxicity scored using Common Toxicity Criteria (CTC) Version 4.0.
次要结局
- Number of VHL Participants With Response at 6 Months(Every 2 cycles (approximately 8 weeks) for 6 months)
研究者
研究点 (1)
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