Phase II Study Of Temozolomide, Thalidomide And Celecoxib In Patients With Newly Diagnosed Glioblastoma Multiforme In The Post-Radiation Setting
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 4
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide and celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor and may increase the effectiveness of temozolomide by making tumor cells more sensitive to the drug.
PURPOSE: Phase II trial to study the effectiveness of combining temozolomide, thalidomide, and celecoxib following radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.
详细描述
OBJECTIVES:
- Determine the efficacy of adjuvant temozolomide, thalidomide, and celecoxib after radiotherapy, in terms of time to tumor progression and overall survival, in patients with newly diagnosed glioblastoma multiforme.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral temozolomide once daily on days 1-5 and oral thalidomide once daily and oral celecoxib twice daily on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed supratentorial glioblastoma multiforme or gliosarcoma
- •Completed standard external beam radiotherapy within the past 5 weeks
- •Stable disease by MRI or CT scan
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 60-100%
- •Life expectancy
- •More than 4 months
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm3
- •Platelet count at least 100,000/mm3
- •No history of bleeding disorder
- •Bilirubin less than 1.5 mg/dL
- •SGPT less than 2.5 times normal
- •Alkaline phosphatase less than 2.5 times normal
- •BUN less than 1.5 times upper limit of normal (ULN) OR
- •Creatinine less than 1.5 times ULN
- •Cardiovascular
- •No deep vein thrombosis within the past 3 weeks (must be clinically stable)
- •No pulmonary embolism within the past 3 weeks (must be clinically stable)
- •Must participate in System for Thalidomide Education and Prescribing Safety program
- •No peripheral neuropathy grade 2 or greater
- •No active infection
- •No concurrent illness that may obscure toxicity or dangerously alter drug metabolism
- •No other serious concurrent illness
- •No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use 2 forms of effective contraception for 1 month before, during, and for 1 month after study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior thalidomide
- •No concurrent immunotherapy
- •No concurrent prophylactic filgrastim (G-CSF)
- •Chemotherapy
- •No prior chemotherapy
- •No other concurrent chemotherapy
- •Endocrine therapy
- •No concurrent hormonal therapy
- •Concurrent corticosteroids must be at stable or decreasing dose over the past 7 days
- •Radiotherapy
- •See Disease Characteristics
- •No concurrent radiotherapy
- •No concurrent surgery
- •No other concurrent anticancer therapy
- •No other concurrent investigational agents
排除标准
- 未提供
研究者
Patrick Y. Wen, MD
Director, Center for Neuro-Oncology
Dana-Farber Cancer Institute