A Phase I Trial of Hypofraction Radiotherapy + Temozolomide in the Treatment of Patients With Glioblastoma Multiforme and Anaplastic Astrocytoma of the Brain
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose(MTD)of Temozolomide(TMZ)
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. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide when given together with radiation therapy in treating patients with newly diagnosed glioblastoma multiforme or anaplastic astrocytoma.
详细描述
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of temozolomide when given in combination with hypofractionated intensity-modulated conformal stereotactic radiotherapy in patients with newly diagnosed de novo glioblastoma multiforme or anaplastic astrocytoma.
Secondary
- To determine the time to neuroradiological evidence of tumor recurrence or progression in patients treated with this regimen.
- To determine the survival time of patients treated with this regimen.
- To determine the time spent in a Karnofsky performance status of 60-100%.
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 who have De novo glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendrogliomas, mixed anaplastic oligoastrocytomas, gliosarcoma of the Brain, not involving the brain stem or optics chiasm, diagnosed following biopsy or tumor removal.
- •Age > 18 years
- •Given written consent
- •Adequate bone marrow reserve(hemoglobin > 10 grams, Absolute neutrophil count > 1500 / mm3, platelets > 100,000/ mm3)
- •Normal renal function(BUN < 24 mg/dL, Creatinine < 1.3 mg/dL)
- •Normal liver function(Total Bilirubin < 1.5 mg/dL, SGPT/ALT < 60 U/L)
排除标准
- •Have a Karnofsky score of < 60 [Appendix B] or age < 18 years.
- •Prior chemotherapy and/or radiotherapy of their glioblastomamultiforme, anaplastic astrocytoma, anaplastic oligodendrogliomas, mixed anaplastic oligoastrocytomas, gliosarcoma.
- •Tumors located in the brainstem or optic chiasm.
- •Prior radiation therapy to the brain
- •Prior chemotherapy within the past 6 weeks.
研究组 & 干预措施
Hypofractionation Radiotherapy+Temozolomide
Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.
干预措施: temozolomide (Drug)
Hypofractionation Radiotherapy+Temozolomide
Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.
干预措施: Hypofractionated radiation therapy (Radiation)
Hypofractionation Radiotherapy+Temozolomide
Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.
干预措施: Intensity-modulated radiation therapy (Radiation)
结局指标
主要结局
Maximum Tolerated Dose(MTD)of Temozolomide(TMZ)
时间窗: up to 12-16 months
This study is designed as a phase I dose escalation trial using the Standard Method of dose escalation of three patients per dose level to determine the MTD of TMZ (up to 75 mg/m 2 /day) when TMZ is used with HIMRT for patients with glioblastoma multiforme(GBM) or Anaplastic Astrocytoma(AA)of the brain. The 3 dose levels will be evaluated using the standard method to determine if either represents an MTD based on DLT. If DLT is not observed at all doses level, the greater of the three levels will be recommended for phase II evaluations of treatment effect.
次要结局
- Time Spent in a Karnofsky Performance Status of 60-100%(up to 12-16 months)
- Time to Neuroradiological Evidence of Tumor Recurrence or Progression(up to 12-16 months)
- Survival Time(up to 2 years)