NCT00006362已完成1 期
A Phase I and Pharmacologic Study of the Proteasome Inhibitor PS-341 in Patients With Advanced Solid Tumors and B-cell Lymphoproliferative Disorders
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 试验地点
- 4
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.
PURPOSE: Phase I trial to study the effectiveness of PS-341 in treating patients who have advanced cancer.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose and toxicity of PS-341 in patients with advanced malignancies.
- Determine, in a preliminary manner, the therapeutic activity of this regimen in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
- Regimen A: Patients receive PS-341 IV twice weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of PS-341 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3-4 or 2 of 6 patients experience dose-limiting toxicity.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 proven advanced malignancy, including non-Hodgkin's lymphoma (NHL), for which there is no known standard therapy that is potentially curative or definitely capable of extending life expectancy
- •Patients with B-cell lymphoproliferative disorders and a leukemic phase are eligible once the maximum tolerated dose is established
- •NHL patients must meet the following conditions:
- •No greater than 25% of bone marrow involved
- •No symptomatic brain metastases
- •Prior brain metastases allowed if definitively treated (radiotherapy and/or surgery) and stable for at least 8 weeks
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/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 (5 times ULN if liver involvement)
- •Creatinine no greater than 1.5 times ULN
- •Cardiovascular:
- •No New York Heart Association class III or IV heart disease
- •No uncontrolled infection
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior biologic therapy or immunotherapy
- •No concurrent immunotherapy
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •No prior radiotherapy to greater than 30% of bone marrow
- •At least 4 weeks since prior radiotherapy
- •No concurrent radiotherapy
- •See Disease Characteristics
- •No concurrent antiretroviral therapy (HAART) for HIV positive patients
排除标准
- 未提供
研究者
研究点 (4)
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