High Dose Sequential Therapy for Poor Risk Recurrent or Refractory Hodgkin's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- Feasibility
研究概览
简要总结
RATIONALE: Giving high-dose chemotherapy before a peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or by killing them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by high-dose chemotherapy and radiation therapy.
PURPOSE: This clinical trial is studying the side effects and how well high-dose chemotherapy works in treating patients undergoing stem cell transplant for recurrent or refractory Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- To evaluate the feasibility and toxicity of high-dose sequential therapy comprising high-dose etoposide and cyclophosphamide with filgrastim (G-CSF) support followed by 2 courses of high-dose therapy and autologous stem cell transplantation in patients with poor-risk recurrent or refractory Hodgkin lymphoma.
- To analyze the response rate, progression-free survival, and overall survival of patients treated with this regimen.
- To determine the percentage of patients who can achieve a minimal disease status after two courses of Hodgkin lymphoma chemotherapy and before "classical autologous stem cell transplantation."
OUTLINE:
- First high-dose chemotherapy*: Patients receive high-dose cyclophosphamide IV over 2 hours followed by etoposide IV over 4 hours.
NOTE: *Patients with minimal disease (i.e., a single lymph node ≤ 2 cm in maximal horizontal diameter or a > 75% reduction in a bulky (≥ 10 cm) tumor mass AND no morphological evidence of active bone marrow disease) at initial evaluation do not receive the first high-dose chemotherapy but proceed directly to peripheral blood stem cell (PBSC) mobilization with filgrastim (G-CSF) for 3 days and PBSC collection beginning on day 4.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SWOG performance status 0-1
- •LVEF > 50% by 2D-ECHO or MUGA scan
- •Patients with LVEF between 45-50% and without wall motion abnormalities are assessed on an individual basis after consultation with the cardiologist
- •FEV_1 or DLCO > 45% predicted
- •Creatinine clearance > 60 mL/min
- •HIV-negative
- •Hepatitis B surface antigen-negative
- •Hepatitis C virus-negative
- •ALT ≤ 5 times upper limit of normal
- •No inadequate vital organ function
- •No active infection
- •Fertile patients must use adequate contraception
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Concurrent, post-transplantation, consolidative radiotherapy to residual masses allowed provided the patient has engrafted with a WBC > 4,000/μL and a platelet count > 100,000/μL
排除标准
- 未提供
结局指标
主要结局
Feasibility
Toxicity as assessed by NCI CTC v2.0
次要结局
- Response rate
- Overall survival
- Percentage of patients who achieve minimal disease status after 2 courses
- Progression-free survival