NCT00047281已完成2 期
Trial Of Oral Thalidomide, Celecoxib, Etoposide And Cyclophosphamide In Adult Patients With Relapsed Or Progressive Malignant Gliomas
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 3
研究概览
简要总结
RATIONALE: Thalidomide and celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide and celecoxib with etoposide and cyclophosphamide may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and celecoxib with etoposide and cyclophosphamide in treating patients who have relapsed or refractory malignant glioma.
详细描述
OBJECTIVES:
- Determine the efficacy of thalidomide, celecoxib, etoposide, and cyclophosphamide, in terms of 6-month progression-free survival, in patients with relapsed or refractory malignant glioma.
- Determine the overall survival of patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the radiographic response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral thalidomide once daily and oral celecoxib twice daily on days 1-42, oral etoposide once daily on days 1-21, and oral cyclophosphamide once daily on days 22-42. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months.
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 intracranial malignant glioma, including glioblastoma multiforme, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, or malignant astrocytoma not otherwise specified
- •Unequivocal evidence of relapsed or refractory disease by MRI or CT scan and/or tumor resection
- •Steroid therapy prior to MRI or CT scan must have been at a stable dose for at least 5 days
- •Failed prior radiotherapy
- •Must have confirmation of true progression rather than radiation necrosis if previously treated with interstitial brachytherapy or stereotactic radiosurgery
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 60-100%
- •Life expectancy
- •More than 2 months
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm3
- •Platelet count at least 100,000/mm3
- •Hemoglobin greater than 9 g/dL
- •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
- •Creatinine less than 1.5 times upper limit of normal (ULN) OR
- •BUN 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)
- •No peripheral neuropathy grade 2 or greater
- •No active infection
- •No other serious concurrent medical illness
- •No concurrent illness that may obscure toxicity or dangerously alter drug metabolism
- •No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •Must participate in the System for Thalidomide Education and Prescribing Safety program
- •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 oral thalidomide or celecoxib for more than 2 months duration
- •Chemotherapy
- •No prior oral etoposide or cyclophosphamide for more than 2 months duration
- •Prior standard-dose IV etoposide and cyclophosphamide allowed
- •Endocrine therapy
- •See Disease Characteristics
- •Concurrent steroids allowed
- •Radiotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior radiotherapy
- •See Disease Characteristics
- •Prior surgery for relapsed or refractory disease allowed
- •Recovered from prior surgery
- •No concurrent surgery
- 另有 3 项未显示
排除标准
- 未提供
研究者
Patrick Y. Wen, MD
Director, Center for Neuro-Oncology
Dana-Farber Cancer Institute
研究点 (3)
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