NCT00014209已完成2 期
A Phase II Study Of Gemcitabine, Dexamethasone, And Cisplatin (GDP) In Patients With Either Hodgkin's Disease Or Aggressive Histology Non-Hodgkin's Lymphoma Which Is Relapsed Or Refractory
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 26
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have Hodgkin's disease or non-Hodgkin's lymphoma that has not responded to previous treatment.
详细描述
OBJECTIVES:
- Determine the efficacy of gemcitabine, dexamethasone, and cisplatin in patients with relapsed or refractory Hodgkin's disease or aggressive non-Hodgkin's lymphoma.
- Determine the qualitative and quantitative toxicity of this regimen in these two patient populations.
OUTLINE: This is a multicenter study. Patients are stratified according to disease (Hodgkin's disease vs non-Hodgkin's lymphoma).
Patients receive oral dexamethasone on days 1-4, cisplatin IV over 1 hour on day 1, and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks, 3 months, and then every 3 months thereafter.
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
- 16 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed Hodgkin's disease OR
- •Histologically or cytologically confirmed aggressive non-Hodgkin's lymphoma (NHL) of B-cell origin (including immunoblastic, anaplastic large cell, mediastinal large B-cell, or T-cell rich B-cell NHL)
- •No prior diagnosis of low-grade NHL
- •No histologic evidence of transformation from indolent to aggressive histology
- •Bidimensionally measurable disease that is clinically or radiologically documented
- •Bone lesions not considered bidimensionally measurable
- •Lymph nodes at least 1.5 cm by 1.5 cm OR
- •Other non-nodal lesions at least 1 cm by 1 cm
- •Recurrent or refractory to 1 prior chemotherapy regimen (excluding gemcitabine and cisplatin)
- •No known CNS involvement NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
- •PATIENT CHARACTERISTICS:
- •16 and over
- •Performance status:
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •Absolute granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •AST or ALT no greater than 2.5 times ULN
- •Creatinine less than 1.6 mg/dL
- •Cardiovascular:
- •No significant cardiac dysfunction or cardiovascular disease
- •HIV negative
- •No other concurrent or prior malignancy within the past 5 years except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
- •No other serious illness or medical condition that would preclude study
- •No active uncontrolled bacterial, fungal, or viral infection
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior stem cell transplantation
- •No concurrent monoclonal antibody therapy
- •No concurrent growth factors during the first course of study
- •Chemotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior IV chemotherapy
- •No prior cisplatin or gemcitabine
- •No prior high-dose chemotherapy
- •No other concurrent cytotoxic therapy
- •Endocrine therapy:
- •No concurrent corticosteroids, except for physiologic replacement
- •Radiotherapy:
- •No prior radiotherapy to more than 25% of functioning bone marrow
- •At least 4 weeks since prior radiotherapy and recovered
- •No concurrent radiotherapy
- •At least 2 weeks since prior major surgery
- •No other concurrent anti-cancer therapy or experimental therapy
排除标准
- 未提供
研究者
研究点 (26)
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