A Phase II Trial of PTK-787 in Recurrent or Progressive Meningiomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- Number of Patients Who DID NOT Experience Disease Progression or Death by 6 Months After Starting Treatment.
研究概览
简要总结
RATIONALE: Vatalanib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well vatalanib works in treating patients with recurrent or progressive meningioma.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of vatalanib, in terms of radiographic improvement and clinical improvement, in patients with recurrent or progressive meningioma.
Secondary
- Determine the 6-month progression-free survival of these patients.
- Describe the response rate and overall survival of these patients.
- Determine the safety of vatalanib in these patients.
- Correlate the response rates with expression of vascular endothelial growth factor, epidermal growth factor receptor, platelet-derived growth factor, and HER2.
- Develop exploratory data concerning surrogate markers of angiogenic activity in vivo using magnetic resonance perfusion.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Vatalanib
Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.
Patients who are responding may remain on study treatment for 12 months.
干预措施: vatalanib (Drug)
结局指标
主要结局
Number of Patients Who DID NOT Experience Disease Progression or Death by 6 Months After Starting Treatment.
时间窗: From the date the first patient began treatment until the date the last patient has disease progression, becomes deceased, or completes 6 months of treatment
Patients were assessed with imaging techniques (MRI) during screening/baseline and then every 2 months after starting treatment. Survival status and disease status were recorded. The number of patients who did not experience an event (defined as either death for any reason or progression of their disease) by 6 months after starting treatment were counted.
次要结局
- Determine Efficacy (Radiographic and Clinical Improvement)(At baseline, every 2 weeks for 2 months, then every 8 weeks while on treatment)
- Best Overall Response Rate (ORR)(Every 2 months for up to 1 year after study treatment.)
- To Correlate the Response Rates With Expression of Certain Types of Genes(At the end of study treatment)
- Safety of Vatalanib in Patients With Recurrent of Progressive Meningiomas(Every week while on study treatment until 30 days after last treatment.)
- Number of Months Patients Survive After Being Treatment on the Study.(From the date the first patient began treatment until the date the last patient became deceased.)
- Overall Survival (OS)(Every 2 months for up to 1 year after study treatment.)
研究者
Jeffrey Raizer
Jeffrey Raizer, MD
Northwestern University