An International, Multi-Center, Randomized, Double Blind Placebo Controlled Phase II Study to Evaluate the Safety and Efficacy of Lucanthone Administered as an Adjunct to Radiation and Temozolomide for Primary Therapy of Glioblastoma Multiforme
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 10
- 主要终点
- Progression Free Survival
研究概览
简要总结
The purpose of the study is to determine the effectiveness of an investigational drug called lucanthone, when combined with temozolomide (TMZ) and radiation in the treatment of Glioblastoma Multiforme (GBM).
详细描述
This is an international, multicenter, randomized, double blind placebo controlled phase II study to evaluate the safety and efficacy of lucanthone administered as an adjunct to patients receiving primary treatment of GBM with temozolomide and radiation. Eligible patients will be randomized to lucanthone or placebo arm in ratio of 1:1. The treatment period will be in two phases ; an initial six weeks of concomitant therapy with temozolomide and radiation, followed by a maintenance phase of six cycles of temozolomide given on Days 1 to 5 of a 28- day cycle (+/- 3 days). Lucanthone / placebo will be given as an add on in both concomitant and maintenance phases.
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
- Double (Participant, Investigator)
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
- •18 and 70 years of age in India, 18 years and above in US
- •Histologically proven GBM who
- •May or may not have undergone surgery
- •Is scheduled to receive treatment with temozolomide and radiation.
- •Karnofsky score ≥ 70%.
排除标准
- •Diagnosis of recurrent brain tumor.
- •Received temozolomide previously.
- •Absolute neutrophil count ≤ 1.5 X 109/L.
- •Screening platelet count < 100 K/uL.
- •Screening bilirubin > 1.6 mg/dL.
- •Screening creatinine > 2.25 mg/dL in men and 1.8 mg/dL in women.
- •Screening ALT or AST > 2.5 times the upper limit of the laboratory reference range.
- •Unstable medical condition or significant comorbid pathophysiology (e.g. active infection, poorly controlled diabetes, unstable angina, severe heart failure) that would interfere with his/her participation in the study.
- •Enrolled, or plans to enroll, in a concurrent treatment protocol with another investigational product.
- •Receiving, or plans to receive, an anti-cancer therapy other than temozolomide during the study.
- •Received prior chemotherapy or radiation therapy within four weeks of enrollment.
研究组 & 干预措施
Placebo
Participants will receive a matching placebo as an adjunct in initial six weeks of concomitant therapy with TMZ and radiation, followed by a maintenance phase of six cycles of TMZ given on Days 1 to 5 of a 28-day cycle (+/- 3 days).
干预措施: Temozolomide (TMZ) (Drug)
Placebo
Participants will receive a matching placebo as an adjunct in initial six weeks of concomitant therapy with TMZ and radiation, followed by a maintenance phase of six cycles of TMZ given on Days 1 to 5 of a 28-day cycle (+/- 3 days).
干预措施: Radiation (Radiation)
Placebo
Participants will receive a matching placebo as an adjunct in initial six weeks of concomitant therapy with TMZ and radiation, followed by a maintenance phase of six cycles of TMZ given on Days 1 to 5 of a 28-day cycle (+/- 3 days).
干预措施: Placebo (Drug)
Lucanthone
Participants will receive Lucanthone as an adjunct in initial six weeks of concomitant therapy with TMZ and radiation, followed by a maintenance phase of six cycles of TMZ given on Days 1 to 5 of a 28-day cycle (+/- 3 days).
干预措施: Lucanthone (Drug)
Lucanthone
Participants will receive Lucanthone as an adjunct in initial six weeks of concomitant therapy with TMZ and radiation, followed by a maintenance phase of six cycles of TMZ given on Days 1 to 5 of a 28-day cycle (+/- 3 days).
干预措施: Temozolomide (TMZ) (Drug)
Lucanthone
Participants will receive Lucanthone as an adjunct in initial six weeks of concomitant therapy with TMZ and radiation, followed by a maintenance phase of six cycles of TMZ given on Days 1 to 5 of a 28-day cycle (+/- 3 days).
干预措施: Radiation (Radiation)
结局指标
主要结局
Progression Free Survival
时间窗: 9 months
Progression Free Survival: defined as the time from randomization until objective tumor progression or death
次要结局
- Safety Profile of Lucanthone(one year)
- Objective response rate (ORR)(one year)
- Overall Survival(one year)