A Phase II Trial of Sunitinib in the Treatment of Recurrent Malignant Gliomas
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- 6-month Progression-free Survival.
研究概览
简要总结
Background:
One way tumors are able to grow is by forming new blood vessels that supply them with nutrients and oxygen.
Sunitinib blocks certain proteins on the surface of tumor and blood vessel cells that are involved with the formation of new blood vessels.
Blocking these proteins may prevent the tumor cells or blood vessels from continuing to grow.
Objectives:
To determine whether sunitinib can cause tumors to shrink or stabilize in patients with recurrent brain cancer.
Eligibility:
Patients 18 years of age or older with brain cancer whose disease has worsened after standard treatment with surgery, radiation.
Design:
Patients take a sunitinib pill once a day in 4-week treatment cycles. Treatment may continue as long as the tumor remains stable or decreases in size and the side effects of treatment are tolerated.
Routine blood tests are done every 2 weeks during the first 8 weeks of treatment and then every 4 weeks after that.
Magnetic resonance imaging (MRI) scans are done before starting treatment (at baseline) and at the end of every 4-week cycle to monitor tumor growth.
Positron emission tomography (PET) scans are done at baseline and at the end of the first cycle.
Neurological and physical examinations are done at baseline, at week 2 of treatment and at the end of every treatment cycle.
Health-related quality of life is assessed every 4 weeks.
Pregnancy tests, electrocardiograms and echocardiograms are repeated as needed.
详细描述
Background:
Solid tumors have multiple mechanisms for stimulating angiogenesis with the vascular endothelial growth factor (VEGF)-kinase insert domain receptor (KDR) axis being only one of them. Sunitinib, through its multiple tyrosine kinase receptor targets, represents an attempt to capitalize on the concept of targeting multiple mechanisms responsible for glioma-associated angiogenesis. Sunitinib inhibits platelet derived growth factor receptor (PDGFR) and c-kit (stem cell factor (SCF) receptor) at nanomolar concentrations. The combination blocks all three known major glioma-mediated angiogenic mechanisms (VEGF, c-kit, PDGF). Based on this scientific rationale, the promising anti-glioma activity of sunitinib in preclinical models, and the promising clinical data in patients with gliomas treated with other VEGF inhibitors, we are now proposing a phase II trial of sunitinib in patients with recurrent malignant gliomas.
Objectives:
To evaluate the anti-glioma activity of sunitinib in patients with recurrent malignant gliomas who are either naive or resistant to prior bevacizumab therapy.
Eligibility:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Bevacizumab resistant patients
Patients who had tumor progression while treated with bevacizumab.
干预措施: Sutent (sunitinib) (Drug)
Bevacizumab naive patients
Patients with progressive tumor who have not been treated with bevacizumab.
干预措施: Sutent (sunitinib) (Drug)
结局指标
主要结局
6-month Progression-free Survival.
时间窗: 6 months
Time between the start of treatment to progression. Progression is defined by the RANO(Response Assessment in Neuro-Oncology) criteria. Progression is defined by any of the following: 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration.
次要结局
- Number of Participants With Adverse Events(7/2/08 -12/6/13)
研究者
Teri Kreisl, M.D.
Principal Investigator
National Institutes of Health Clinical Center (CC)