Phase II Trial for Patients With Newly Diagnosed Glioblastoma Multiforme (GBM) Treated With Gliadel Followed by Concurrent Radiation Therapy, Temodar and Avastin, Then Followed by Avastin and Temodar Post-Radiation
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- 21-month Overall Survival
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of Gliadel wafers at the time of surgery, followed by the combination of radiation, Temodar, and Avastin, and then the combination of Avastin and Temodar, after radiation is complete, on malignant brain tumors.
About six weeks after surgery, subjects will begin standard radiation therapy, a fixed dose of Avastin every 2 weeks, and daily Temodar for the six and a half weeks of radiation. Beginning 2-3 weeks after the last radiation therapy, subjects will be given the same fixed dose of Avastin intravenously (through the vein) every 14 days. They will also be given a higher dose of oral Temodar to take daily the first 5 days of each 28-day study cycle.
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
- •Patients must have a MRI consistent with a WHO grade IV primary malignant glioma (glioblastoma multiforme or gliosarcoma), and be candidates for surgical resection with Gliadel wafer placement. Patients have to be within 6 weeks of the last major surgical procedure.
- •Age ≥ 18 years
- •Candidates for Gliadel
- •If a prior procedure was done, an interval of at least 2 weeks and not > 8 weeks between prior major surgical procedure and study enrollment
- •No prior radiotherapy or chemotherapy for a brain tumor
- •Karnofsky > 60%
- •Hemoglobin ≥ 9.0 g/dl, ANC ≥ 1,500 cells/microliters, platelets ≥ 125,000 cells/microliters
- •Serum creatinine ≤ 1.5 mg/dl, serum SGOT and bilirubin ≤ 1.5 times upper limit of normal.
- •Signed informed consent approved by the Institutional Review Board
- •If sexually active, patients must agree to use appropriate contraceptive measures for the duration of the study and for 6 months afterwards as stated in the informed consent.
排除标准
- •Pregnancy or breast feeding.
- •Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids.
- •Active infection requiring IV antibiotics.
- •Prior treatment with radiotherapy or chemotherapy for a brain tumor, irrespective of the grade of the tumor.
- •Evidence of > grade 1 CNS hemorrhage on baseline MRI or CT scan.
- •Prior treatment with Avastin for any condition
- •Prior, unrelated malignancy requiring active treatment with the exception cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin
- •Avastin-Specific Exclusion Criteria:
- •Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or diastolic blood pressure > 100 mmHg)
- •Prior history of hypertensive crisis or hypertensive encephalopathy
- •New York Heart Association (NYHA) Grade II or greater congestive heart failure
- •History of myocardial infarction or unstable angina within 6 months prior to study enrollment
- •History of stroke or transient ischemic attack within 6 months prior to study enrollment
- •Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to study enrollment
- •History of hemoptysis (≥ ½ teaspoon of bright red blood per episode) within 1 month prior to study enrollment
- •Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the first Avastin infusion or anticipation of need for major surgical procedure during the course of the study
- •Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
- •History of abdominal fistula, gastrointestinal perforation within 6 months prior to study enrollment
- •Serious, non-healing wound, active ulcer, or untreated bone fracture
- •Proteinuria at screening as demonstrated by urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).
- •Known hypersensitivity to any component of Avastin
- •Pregnant (positive pregnancy test) or lactation. Use of effective means of contraception (men and women) in subjects of child-bearing potential
研究组 & 干预措施
Gliadel, Radiation Therapy, Avastin, Temodar
Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation
干预措施: Gliadel (Drug)
Gliadel, Radiation Therapy, Avastin, Temodar
Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation
干预措施: Radiation Therapy (Radiation)
Gliadel, Radiation Therapy, Avastin, Temodar
Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation
干预措施: Avastin (Drug)
Gliadel, Radiation Therapy, Avastin, Temodar
Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation
干预措施: Temodar (Drug)
结局指标
主要结局
21-month Overall Survival
时间窗: 21 months
The percentage of participants alive at 21 months after the start of study treatment. Overall survival was calculated from the date study treatment started until the date of death or the date of last follow-up if alive. Kaplan-Meier methods were used to estimate overall survival.
次要结局
- Median Overall Survival(21 months)
- Median Progression-free Survival(21 months)
- Unacceptable Toxicity Related to the Treatment Regimen(27 months)