A Phase II Study Of Gemcitabine, Cisplatin, and Dexamethasone In Patients With Relapsed Or Refractory Hodgkin Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, cisplatin, and dexamethasone, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine and cisplatin together with dexamethasone works in treating patients with relapsed or refractory Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Determine the response rate and maximum response in patients with relapsed or refractory Hodgkin's lymphoma treated with gemcitabine, cisplatin, and dexamethasone.
- Determine time to progression in patients treated with this regimen who are not undergoing stem cell transplantation.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive gemcitabine IV over 1 hour on days 1 and 8, cisplatin IV over 3 hours on day 1, and oral dexamethasone twice daily on days 1-4. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed until disease progression.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Diagnosis of Hodgkin's lymphoma
- •Measurable disease by radiological or clinical findings
- •Failed at least 1, but no more than 2, prior standard chemotherapy regimens
- •High-dose chemotherapy administered after a chemotherapy course is considered 2 courses
- •No evidence of CNS disease
- •No history of myelodysplastic syndromes
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC > 2,000/mm^3
- •Absolute neutrophil count > 1,500/mm^3
- •Platelet count > 75,000/mm^3
- •Hemoglobin > 8.0 g/dL
- •Bilirubin < 2 times upper limit of normal (ULN)
- •AST and ALT < 5 times ULN
- •Creatinine < 1.5 times ULN
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for 3 months after study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •See Disease Characteristics
- •No prior gemcitabine
- •More than 6 months since prior high-dose chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
排除标准
- 未提供