NCT00005580已完成1 期
Phase I Study of Bryostatin 1 (NSC 339555) and Fludarabine in Patients With Chronic Lymphocytic Leukemia and Indolent Non-Hodgkin's Lymphoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 3
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. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 plus fludarabine in treating patients who have chronic lymphocytic leukemia or relapsed, indolent non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Determine the toxic effects and maximum tolerated dose of bryostatin 1 and fludarabine in patients with symptomatic or advanced chronic lymphocytic leukemia or relapsed indolent non-Hodgkin's lymphoma.
- Monitor apoptosis, differentiation, and protein kinase C activity in leukemic lymphocytes exposed in vivo to bryostatin 1 and fludarabine.
- Observe the antitumor activity of this combination therapy in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are assigned to one of two treatment groups.
- Group I: Patients receive bryostatin 1 IV over 24 hours followed by fludarabine IV over 30 minutes daily on days 1-5.
- Group II: Patients receive fludarabine IV over 30 minutes daily on days 1-5 followed by bryostatin 1 IV over 24 hours.
In both groups, courses repeat every 4 weeks for patients with stable or responding disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 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:
- •Histologically confirmed chronic lymphocytic leukemia
- •Stage I (symptomatic or with bulky lymphadenopathy)
- •Stage II, III, or IV
- •Prior chemotherapy allowed, including fludarabine or other purine nucleoside analog therapy OR
- •Histologically confirmed indolent non-Hodgkin's lymphoma
- •Progressive or relapsed following chemotherapy
- •Includes the following histologies:
- •B-cell chronic lymphocytic leukemia/prolymphocytic leukemia/lymphomas
- •Lymphoplasmacytoid lymphoma (Waldenstrom's)/immunocytoma
- •Mantle cell lymphoma
- •Follicular lymphoma
- •Small cell
- •Mixed small and large cell
- •Diffuse (predominately small cell type)
- •Marginal zone B-cell lymphoma
- •Extranodal (MALT-type with or without monocytoid B-cells)
- •Provisional subtype: nodal (with or without monocytoid B-cells)
- •Provisional entity: splenic marginal zone lymphoma (with or without villous lymphocytes)
- •Hairy cell leukemia
- •Peripheral T-cell and NK-cell neoplasms
- •T-cell chronic lymphocytic leukemia/polylymphocytic leukemia
- •Large granular lymphocyte leukemia
- •T-cell type
- •NK-cell type
- •Mycosis fungoides/Sezary's syndrome (cutaneous T-cell lymphoma)
- •No CNS disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Zubrod 0-2
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Granulocyte count at least 1,000/mm3
- •Platelet count at least 75,000/mm3
- •Hemoglobin at least 8 g/dL
- •Coombs negative
- •AST/ALT no greater than 2.5 times upper limit of normal
- •Bilirubin no greater than 2 mg/mL
- •Creatinine clearance at least 40 mL/min
- •No concurrent neurologic condition
- •No other concurrent medical condition that would preclude study
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for 3 months after study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent systemic immunoglobulin therapy
- •No prior bone marrow or peripheral stem cell transplantation
- •Chemotherapy:
- 另有 8 项未显示
排除标准
- 未提供
研究者
研究点 (3)
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