A Phase I/II Study of Methylselenocysteine (MSC) in Combination With Immunochemotherapy (R-ICE) in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 10
- 主要终点
- Dose-limiting toxicity and maximum tolerated dose of Se-methyl-seleno-L-cysteine (MSC) (Phase I)
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer cell-killing substances to them. Drugs used in chemotherapy, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Se-methyl-seleno-l-cysteine may help reduce the side effects of chemotherapy.
PURPOSE: This phase I/II trial is studying the side effects and best dose of Se-methyl-seleno-l-cysteine when given together with rituximab, ifosfamide, carboplatin, and etoposide and to see how well it works in treating patients with diffuse large B-cell lymphoma that has relapsed or not responded to treatment.
详细描述
OBJECTIVES:
Primary
- To assess dose-limiting toxicity and maximum-tolerated dose (MTD) of Se-methyl-seleno-L-cysteine (MSC) (to achieve a trough serum selenium [Se] concentration of > 20 μmol/L) prior to and in combination with rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in patients with relapsed or refractory diffuse large B-cell lymphoma. (Phase I)
- To determine the overall response rate to R-ICE given in addition to MSC at the MTD in these patients. (Phase II)
Secondary
- To determine the toxicity of R-ICE when used in combination with MSC in these patients.
- To determine the effect of MSC dosing on serum and intracellular Se and Se species in these patients.
- To determine the pharmacokinetics of MSC after single and multiple daily dosing in these patients.
- To investigate the effect of MSC dosing on Se-dependent processes (e.g., NFκB activity and AKT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
结局指标
主要结局
Dose-limiting toxicity and maximum tolerated dose of Se-methyl-seleno-L-cysteine (MSC) (Phase I)
Overall response rate (Phase II)
次要结局
- Toxicity as assessed by NCI CTCAE v 3.0
- Serum and intracellular Se and Se species
- Pharmacokinetics of MSC
- Protein markers of selenium activity