PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation: A Randomized Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 9
- 主要终点
- Progression Free Survival PPX/RT Versus TMZ/RT for Patients With GBM Without Methylation
研究概览
简要总结
To obtain preliminary data in a randomized phase II study whether PPX/RT improves progression-free survival as compared to temozolomide/RT for patients with GBM without MGMT methylation.
详细描述
To evaluate the toxicities of PPX/RT To evaluate neuro-cognitive functional assessments of patients with GBM receiving PPX/RT To obtain preliminary data in a randomized phase II study whether PPX/RT improves overall survival as compared to temozolomide /RT for patients with GBM without MGMT methylation to facilitate planning a phase III study.
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
- •Histologically proven diagnosis of glioblastoma or gliosarcoma (WHO grade IV)
- •GBM must have unmethylated MGMT as determined by central laboratory
- •Diagnosis of GBM must be made by biopsy or surgical excision, either partial or complete; as long as there is sufficient tissue to determine MGMT status
- •No prior chemotherapy or radiation for brain tumor
- •Must be able to tolerate brain MRIs.
- •*A diagnostic contrast-enhanced MRI must be performed postoperatively within 42 days prior to study registration.
- •Age > 18
- •Life expectancy of at least 3 months.
- •Absolute neutrophil count > 1500/mm3, Platelets > 100,000/mm,
- •Creatinine < 2 x ULN
- •ALT or AST < 3 x upper limit of normal (ULN) and total bilirubin < 1.5x ULN.
- •Patients with a prior history of low grade glioma who did not receive prior radiation or chemotherapy with transformation to grade IV brain tumor are eligible.
- •Women must be non-lactating, and surgically sterile, post-menopausal or have a negative serum pregnancy test and agree to use adequate birth control. Males must agree to use adequate birth control.
- •Voluntary, signed informed consent.
排除标准
- •Acute infection or other medical condition that would impair study treatment
- •No other active invasive malignancy unless disease free for at least 3 years.
- •Prior temozolomide or PPX.
- •Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted.
- •Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields.
- •No diffuse leptomeningeal disease, or gliomatosis cerebri.
- •Use of any other experimental chemotherapy drug within the 60 days prior to randomization and during the trial. (Use of a non-chemotherapy investigational agent must be approved by the Brown University Oncology Group)
研究组 & 干预措施
radiation plus PPX(CT2103
Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments
- intravenous PPX every week x 6 weeks for a total of 6 treatments
干预措施: PPX (CT2103) (Drug)
radiation + Temozolomide
Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments
- Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days
干预措施: Temozolomide (Drug)
结局指标
主要结局
Progression Free Survival PPX/RT Versus TMZ/RT for Patients With GBM Without Methylation
时间窗: Q 3 months on study then Q3 months in f/u for yr 1, q 4 months yr 2, q 6 months for approximately 4 ys.
MRI response evaluated by RANO criteria * Complete Response (CR): Circumstance when the enhancing tumor is no longer seen by neuroimaging, with the patient off all steroids or on adrenal maintenance only; CR will be coded only if confirmed by a second CT/MR scan performed a minimum of 4 weeks after the initial scan coding a response. * Partial Response (PR): Decrease of \> 50% in the product of two diameters. Patients should be receiving stable or decreasing doses of steroids. PR will be coded only if confirmed by a second CT/MR scan performed a minimum of 4 weeks after the initial scan. * Progression (P): A \> 25% increase in tumor area (two diameters) provided that the patient has not had his/her dose of steroids decreased since the last evaluation period. This will not need a confirmatory scan. A concomitant decrease in steroid dose will rule out a progression designation during the first 2 months after completion of XRT.
次要结局
未报告次要终点
研究者
howard safran
Principal Investigator
Brown University