Phase II Study of Temozolomide and Radiation in Newly Diagnosed GBM Patients After Resection and Insertion of Gliadel® Wafers
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Death
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving temozolomide during and after radiation therapy may kill any tumor cells that remain after surgery and placement of Gliadel wafers.
PURPOSE: This phase II trial is studying how well giving temozolomide during and after radiation therapy works in treating patients who have undergone previous surgery and placement of Gliadel wafers for newly diagnosed glioblastoma multiforme.
详细描述
OBJECTIVES:
- Determine the efficacy of adjuvant temozolomide when administered during and after external beam radiotherapy, in terms of survival, in patients with newly diagnosed glioblastoma multiforme who have undergone prior total surgical resection and placement of polifeprosan 20 with carmustine implant (Gliadel® wafers).
OUTLINE: This is an open-label study.
Patients undergo external beam radiotherapy 5 days a week for 6 weeks and concurrently receive oral temozolomide once daily for 6 weeks. No more than 28 days later, patients receive additional oral temozolomide once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 2 months 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 grade IV astrocytoma (glioblastoma multiforme)
- •Underwent gross total resection within the past 6 weeks
- •Postoperative contrast-enhancing tumor extends ≤ 1 cm from the margin of the surgical cavity
- •6-8 polifeprosan 20 with carmustine implants (Gliadel® wafers) were placed in the surgical resection cavity at time of surgery
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 60-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 1.5 mg/dL
- •Transaminases ≤ 4 times upper limit of normal
- •Creatinine ≤ 1.7 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No known hypersensitivity reaction to temozolomide
- •No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior immunotherapy for the brain tumor
- •No prior biologic agents (e.g., immunotoxins, immunoconjugates, antisense agents, peptide-receptor agonists, interferons, interleukins, tumor-infiltrating lymphocyte therapy, lymphokine-activated killer cell therapy, or gene therapy) for the brain tumor
- •Chemotherapy
- •See Disease Characteristics
- •No other prior chemotherapy for the brain tumor
- •Endocrine therapy
- •No prior hormonal therapy for the brain tumor
- •Prior glucocorticoid therapy allowed
- •Radiotherapy
- •No prior radiotherapy for the brain tumor
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Death
次要结局
未报告次要终点