Phase II Trial of Bevacizumab Plus Etoposide for Patients With Recurrent Malignant Glioma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- 6 Month Progression-Free Survival (PFS)
研究概览
简要总结
Primary Objective to estimate 6-month progression free survival probability of patients with recurrent malignant glioma treated with Etoposide + Bevacizumab.
Secondary Objectives To evaluate safety & tolerability of Etoposide + Bevacizumab among patients with recurrent malignant glioma (RMG).
To evaluate radiographic response, progression free survival & overall survival of patients with recurrent malignant glioma treated with Etoposide + Bevacizumab.
详细描述
Exploratory, single-arm, ph II study designed to assess anti-tumor activity of combinatorial regimen consisting of Etoposide + Bevacizumab among patients with RMG. Primary endpoint of study is probability of progression-free survival at 6 months. Important secondary objective is to further assess safety of Etoposide & Bevacizumab for patients with recurrent malignant glioma.
If study demonstrates that combinatorial regimen of Etoposide + Bevacizumab is associated with encouraging anti-tumor activity among patients with RMG, further assessment of regimen in additional phase II & possibly phase III studies, will be considered.
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
- •Pts have confirmed diagnosis of recurrent/progressive WHO gr III & IV MG
- •Age >18 rs
- •Interval of >4 wks since prior surgery
- •Interval of >4 wks since prior XRT/chemo, unless there is unequivocal evidence of progressive disease & pts have recovered from all anticipated toxicity of most recent therapy;
- •Karnofsky performance status score >60
- •Hematocrit >29 percent, ANC >1,500 cells/microliter, platelets >100,000 cells/microliter
- •Serum creatinine <1.5 mg/dl, BUN <25 mg/dl, serum SGOT & bilirubin <1.5 x ULN
- •For pts on corticosteroids, they have been on astable dose for 1wk prior to entry
- •Signed informed consent approved by IRB prior to pt entry
- •If sexually active, pts must agree to take contraceptive measures for duration of treatments.
排除标准
- •Prior therapy w either bevacizumab/etoposide
- •>3 prior recurrences
- •Pregnancy/breast feeding
- •Co-medication w immuno-suppressive agents other than corticosteroids including but not limited to cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil
- •Evidence of CNS hemorrhage on baseline MRI on CT scan
- •Pts who require therapeutic anti-coagulation
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring IV antibiotics & psychiatric illness/social situations that would limit compliance w study requirements, or disorders associated w significant immunocompromised state
- •Pts w another primary malignancy that has required treatment <past year
研究组 & 干预措施
Bevacizumab + Etoposide
Grade III and IV patients will receive: Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1st bevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day.
干预措施: Bevacizumab and Etoposide (Drug)
结局指标
主要结局
6 Month Progression-Free Survival (PFS)
时间窗: 6 months
Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression. Progression was defined as greater than or equal to a 25% increase in the product of the largest perpendicular diameters of any enhancing lesion or any new enhancing tumor on MRI scans.
次要结局
- Objective Response Rate(2 years)
- Safety of Study Treatment Regimen(2 years)
- Median Progression-Free Survival(Patients were followed for a median of 91.4 weeks)
- Median Overall Survival (OS)(median of 91.4 weeks)