Phase I Trial of Bortezomib (PS-341; NSC 681239) and Alvocidib (Flavopiridol NSC 649890) in Patients With Recurrent or Refractory Indolent B-Cell Neoplasms
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 5
- 主要终点
- Recommended phase II dose
研究概览
简要总结
Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as flavopiridol, work in different ways to stop cancer cells from dividing so they stop growing or die. Bortezomib may increase the effectiveness of flavopiridol by making cancer cells more sensitive to the drug. Giving bortezomib together with flavopiridol may kill more cancer cells. This phase I trial is studying the side effects and best dose of bortezomib and flavopiridol in treating patients with recurrent or refractory indolent B-cell neoplasms.
详细描述
PRIMARY OBJECTIVES:
I. To determine the recommended phase II dose of bortezomib and flavopiridol in patients with recurrent or refractory indolent B-cell neoplasms.
SECONDARY OBJECTIVES:
I. To determine the toxic effects and maximum tolerated dose of this regimen in these patients.
II. To determine disease-related effects of this regimen in these patients. III. To determine the pharmacodynamics of this regimen in patients with myeloma.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •WBC < 50,000/mm^3 for patients with circulating tumor cells
- •No prior allergic reaction to compounds of similar chemical or biological composition to and presumably able to tolerated bortezomib, flavopiridol, allopurinol, sodium polystyrene sulfonate, or dexamethasone
- •No neuropathy >= grade 2
- •No other condition that would preclude study participation
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for 3 months after study participation
- •Prior autologous stem cell transplantation is allowed
- •No prior allogeneic stem cell transplantation
- •No other concurrent anticancer agents
- •No other concurrent investigational agents
- •Hemoglobin >= 8 g/dL
- •Platelet count >= 100,000/mm^3
- •Absolute neutrophil count >= 1,500/mm^3
- •Bilirubin =< 2 times upper limit of normal (ULN)
- •AST/ALT =< 3 times ULN
- •Creatinine =< 2 times ULN or Creatinine clearance >= 50 mL/min
排除标准
- 未提供
研究组 & 干预措施
Treatment
Patients receive bortezomib IV over 3-5 seconds followed by flavopiridol IV over 1 hour on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: Bortezomib (Drug)
Treatment
Patients receive bortezomib IV over 3-5 seconds followed by flavopiridol IV over 1 hour on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: Alvocidib Hydrochloride (Drug)
Treatment
Patients receive bortezomib IV over 3-5 seconds followed by flavopiridol IV over 1 hour on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: Pharmacological Study (Other)
结局指标
主要结局
Recommended phase II dose
时间窗: 21 days
次要结局
- Survival(Up to 8 years)
- Maximum tolerated dose, assessed according to NCI CTCAE v4.0(21 days)
- Response duration(Up to 8 years)
- Time to progression(Up to 8 years)
- Response(Up to 8 years)