A Phase II Study of Arsenic Trioxide in Combination With Thalidomide, Dexamethasone, and Ascorbic Acid
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Response rate (complete response, partial response, and minimal response) as measured by bone marrow aspirate, biopsy, cytogenetic analysis, serum, urine, and immunofixation skeletal survey at 6 months and end of study treatment
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, dexamethasone, and ascorbic acid, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Sometimes when chemotherapy is given, it does not stop the growth of cancer cells. The cancer is said to be resistant to chemotherapy. Giving arsenic trioxide together with chemotherapy may reduce drug resistance and allow the cancer cells to be killed. Thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Giving arsenic trioxide together with thalidomide, dexamethasone, and ascorbic acid may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with thalidomide, dexamethasone, and ascorbic acid works in treating patients with relapsed or refractory multiple myeloma.
详细描述
OBJECTIVES:
- Determine the safety and side effects of arsenic trioxide administered in combination with thalidomide, dexamethasone, and ascorbic acid in patients with relapsed or refractory multiple myeloma.
- Determine, preliminarily, the anticancer effects of this regimen in these patients.
- Determine the duration of anticancer effects in patients treated with this regimen.
- Determine the effect of this regimen on bone and immune function in these patients.
OUTLINE: Patients receive arsenic trioxide IV continuously and oral ascorbic acid once daily on days 1-5 in week 1 and twice weekly in weeks 2-12 and oral thalidomide once daily in weeks 1-14. Treatment with arsenic trioxide, ascorbic acid, and thalidomide repeats every 14 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral dexamethasone once daily on days 1-4. Treatment with dexamethasone repeats every 28 days.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
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
Arsenic Trioxide
Arsenic Trioxide in Combination With Thalidomide, Dexamethasone, and Ascorbic Acid
干预措施: ascorbic acid (Dietary Supplement)
Arsenic Trioxide
Arsenic Trioxide in Combination With Thalidomide, Dexamethasone, and Ascorbic Acid
干预措施: arsenic trioxide (Drug)
Arsenic Trioxide
Arsenic Trioxide in Combination With Thalidomide, Dexamethasone, and Ascorbic Acid
干预措施: dexamethasone (Drug)
Arsenic Trioxide
Arsenic Trioxide in Combination With Thalidomide, Dexamethasone, and Ascorbic Acid
干预措施: thalidomide (Drug)
结局指标
主要结局
Response rate (complete response, partial response, and minimal response) as measured by bone marrow aspirate, biopsy, cytogenetic analysis, serum, urine, and immunofixation skeletal survey at 6 months and end of study treatment
次要结局
- Safety and tolerability as measured by physical exams, blood tests, and adverse events reports weekly