A Phase I/II Trial of Arsenic Trioxide and Temozolomide in Combination With Radiation Therapy for Patients With Malignant Gliomas
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Maximum tolerated dose of arsenic trioxide and temozolomide in combination with radiotherapy
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and 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 arsenic trioxide and temozolomide together with radiation therapy after surgery may kill any remaining tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of arsenic trioxide and temozolomide when given together with radiation therapy and to see how well they work in treating patients with malignant glioma that has been removed by surgery.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) of arsenic trioxide and temozolomide when combined with radiotherapy in patients with resected supratentorial malignant glioma. (Phase I)
- Determine the toxicity of this regimen in these patients. (Phase I)
Secondary
- Determine the 6- and 12-month progression-free survival of patients treated with this regimen once an MTD is reached. (Phase II)
- Determine the radiographic response for patients treated with the above regimen. (Phase II)
- Determine the safety of this regimen in these patients. (Phase II)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Radiation + temozolomide and arsenic trioxide
Radiation therapy followed by the combination of temozolomide and arsenic trioxide at the maximum tolerated dose determined in phase 1
干预措施: arsenic trioxide (Drug)
Radiation + temozolomide and arsenic trioxide
Radiation therapy followed by the combination of temozolomide and arsenic trioxide at the maximum tolerated dose determined in phase 1
干预措施: temozolomide (Drug)
Radiation + temozolomide and arsenic trioxide
Radiation therapy followed by the combination of temozolomide and arsenic trioxide at the maximum tolerated dose determined in phase 1
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Maximum tolerated dose of arsenic trioxide and temozolomide in combination with radiotherapy
时间窗: Toxicity evaluated prior to each treatment cycle
Escalating doses of study drug until dose limiting toxicities are observed.
Assess serum biomarkers and correlate with tumor tissue
时间窗: At baseline, during radiation therapy, and prior to each cycle of chemotherapy
Blood will be drawn at baseline, during radiation therapy, and prior to each cycle of chemotherapy to assess serum biomarkers and correlate with tumor tissue.
Collect data on the toxicity of arsenic and temozolomide during radiation therapy
时间窗: Toxicity evaluated prior to each treatment cycle
Toxicity of this drug combination during radiation therapy will be assessed.
次要结局
- Determine progression free survival at 6 and 12 months(At 6 and 12 months after beginning chemotherapy)
- To determine radiographic response to study regimen(Every 6 months while on treatment)
- To collect safety data during the radiation therapy phase(Weekly during radiation therapy)
- To evaluate a potential surrogate marker for outcomes(At baseline, before and after radiation therapy, and every 2 cycles during chemotherapy)
- Determine time to disease progression(At 6 and 12 months after beginning chemotherapy)
- To determine overall survival(Every 6 months while on treatment)