A Phase II Trial Involving Patients With Recurrent PCNSL Treated With Carboplatin/BBBD, by Adding Rituxan (Rituximab), An Anti CD-20 Antibody, To The Treatment Regimen
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Number of Participants With a Complete Response Rate to Chemotherapy Regimen Assessed by Radiographic Response at 2 Years.
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, etoposide phosphate, and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Osmotic blood-brain barrier disruption uses certain drugs to open the blood vessels around the brain and allow anticancer substances to be delivered directly to the brain tumor. Chemoprotective drugs such as sodium thiosulfate may protect normal cells from the side effects of carboplatin-based chemotherapy. Combining rituximab with chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate in treating patients who have refractory or recurrent primary CNS lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of rituximab, carboplatin, cyclophosphamide, etoposide or etoposide phosphate and cytarabine administered in conjunction with osmotic blood-brain barrier disruption and high-dose sodium thiosulfate, in terms of complete response rate, in patients with refractory or recurrent primary CNS lymphoma.
Secondary
- Determine the overall survival and 2-year progression-free survival of patients treated with this regimen.
- Determine the quality of life and cognitive function of patients treated with this regimen.
- Determine the neurotoxicity of this regimen in these patients.
- Determine the percentage of patients with ototoxicity over time after treatment with this regimen.
- Determine the effect of delayed administration of sodium thiosulfate on granulocyte and erythrocyte counts in these patients.
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 Months 至 75 Years（Child, 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
All subjects
干预措施: Etoposide phosphate (Drug)
All subjects
干预措施: Rituxan (Drug)
All subjects
干预措施: Cyclophosphamide (Drug)
All subjects
干预措施: Etoposide (Drug)
All subjects
干预措施: Carboplatin (Drug)
All subjects
干预措施: Sodium thiosulfate (Drug)
All subjects
干预措施: Neupogen (Drug)
All subjects
干预措施: Neulasta (Drug)
All subjects
干预措施: Cytarabine (Drug)
结局指标
主要结局
Number of Participants With a Complete Response Rate to Chemotherapy Regimen Assessed by Radiographic Response at 2 Years.
时间窗: 2 years
Per RECIST criteria (v1.1) and assessed by magnetic resonance imaging (MRI): Complete response (CR), Disappearance of all target lesions.
次要结局
- Number of Participants With Overall Survival Assessed by Clinical and Radiographic Response(5 years)
- Progression-free Survival Assessed by Clinical and Radiographic Response From First Day of Treatment Until Tumor Progression(5 years)
- Quality of Life Assessed by EORTC QOL Before Treatment and Then Every 3 Months(5 years)
- Ototoxicity Assessed by Audiology Hearing Test Done Monthly During Treatment(2 years)
- Effect of Sodium Thiosulfate (STS) on Granulocytes and Erythrocytes Assessed by Complete Blood Count Lab Values Done Weekly During Treatment(2 years)
研究者
Edward Neuwelt
Professor
OHSU Knight Cancer Institute