A Phase II Trial of Ifosfamide, Carboplatin, and Etoposide (ICE) Chemotherapy in Combination With Rituximab as Salvage Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy combined with rituximab in treating patients who have recurrent or refractory non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Determine the chemosensitivity rate in patients with recurrent or refractory non-Hodgkin's lymphoma treated with ifosfamide, carboplatin, and etoposide (ICE) in combination with rituximab.
- Determine whether the addition of rituximab changes the toxicity profile of the ICE chemotherapy regimen in these patients.
OUTLINE: Patients receive rituximab IV on days 1, 8, and 15 and ifosfamide IV over 1 hour, etoposide IV over 2 hours, and carboplatin IV on days 2-4. Treatment continues every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients who are not candidates for autologous stem cell transplantation may receive 1-4 more courses of chemotherapy without rituximab.
Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 19-39 patients will be accrued for this study within 2 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 19 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed recurrent or refractory B-cell non-Hodgkin's lymphoma
- •o CD20 positive
- •Bidimensionally measurable or evaluable disease
- •19 years old and over
- •ECOG 0-2 or Karnofsky 70-100%
- •Life expectancy at least 3 months
- •WBC at least 3,000/mm3
- •Granulocyte count at least 1,000/mm3
- •Platelet count at least 100,000/mm3
- •Bilirubin no greater than 1.5 times upper limit of normal(ULN)
- •AST or ALT no greater than 2.5 times ULN
- •Creatinine no greater than 1.5 mg/dL
- •Fertile patients must use effective contraception
- •Concurrent non-steroidal hormonal therapy allowed for non-disease related conditions (e.g., insulin for diabetes)
排除标准
- •No myelodysplastic syndrome or chronic myeloid leukemia
- •Not pregnant or nursing/negative pregnancy test
- •No other prior malignancy except curatively treated basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix
- •No active serious infection
- •No other concurrent serious medical condition that would preclude study
- •No prior bone marrow or peripheral blood stem cell transplantation for non-Hodgkin's lymphoma
- •No other concurrent chemotherapy
- •No concurrent corticosteroids except transient administration as antiemetic
- •No concurrent radiotherapy
- •No other concurrent investigational therapy
- •No other concurrent antitumor agents