Pilot Study Evaluating Aprepitant (MK-869) for Prevention of Nausea & Vomiting Secondary to High Dose Cyclophosphamide Administered to Patients Underging Undergoing Peripheral Hematopoietic Progenitor Cell Mobilization Prior to Autologous Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proportion of Participants With Controlled Acute Vomiting
研究概览
简要总结
RATIONALE: Antiemetic drugs, such as aprepitant, granisetron, and dexamethasone, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy.
PURPOSE: This clinical trial is studying how well giving aprepitant together with granisetron and dexamethasone works in preventing nausea and vomiting in patients receiving cyclophosphamide before undergoing an autologous stem cell transplant.
详细描述
OBJECTIVES:
Primary
- Evaluate the efficacy of the addition of aprepitant in controlling acute vomiting with the standard prophylactic anti-emetic combination of granisetron hydrochloride and dexamethasone in patients receiving therapy comprising high-dose cyclophosphamide to mobilize stem cells prior to leukapheresis for autologous stem cell transplantation.
Secondary
- Evaluate the efficacy of the addition of aprepitant in controlling delayed vomiting in these patients.
- Evaluate the efficacy of the addition of aprepitant in controlling overall nausea in these patients.
- Identify side effects of the addition of aprepitant to this regimen 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
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（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
Aprepitant, Dexamethasone, Cytoxan & Kytril
Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.
Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.
Days 2 & 3: Aprepitant 80 mg once daily in the morning.
干预措施: Granisetron hydrochloride (Drug)
Aprepitant, Dexamethasone, Cytoxan & Kytril
Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.
Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.
Days 2 & 3: Aprepitant 80 mg once daily in the morning.
干预措施: Cyclophosphamide (Drug)
Aprepitant, Dexamethasone, Cytoxan & Kytril
Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.
Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.
Days 2 & 3: Aprepitant 80 mg once daily in the morning.
干预措施: Dexamethasone (Drug)
Aprepitant, Dexamethasone, Cytoxan & Kytril
Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.
Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.
Days 2 & 3: Aprepitant 80 mg once daily in the morning.
干预措施: Aprepitant (Drug)
结局指标
主要结局
Proportion of Participants With Controlled Acute Vomiting
时间窗: at 0-24 hours
No episodes of vomiting and no rescue medication during first 24 hours after cyclophosphamide administration.
次要结局
- Delayed Vomiting Controlled(at 25-120 hours)
- Toxicity Grade 3, 4, or 5(at 0-120 hours)
研究者
Muneer Abidi
Principal Investigator
Barbara Ann Karmanos Cancer Institute