NCT00005794已完成1 期
A Phase I Trial of Perifosine on a Loading Dose/Maintenance Dose Schedule in Patients With Advanced Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Perifosine may stop the growth of tumor cells by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of perifosine in treating patients who have advanced solid tumors.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of perifosine on a loading dose/maintenance dose schedule in patients with advanced solid tumors.
- Determine the qualitative and quantitative toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Investigate the relationship between pharmacokinetic parameters and toxicity of this drug in these patients.
- Determine the recommended starting dose for phase II trials on this drug schedule in these patients.
- Evaluate the pharmacodynamic parameters on peripheral blood lymphocytes both before and during drug administration in these patients.
- Determine any changes in the MTD with prolonged administration (3 months, 6 months) of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive a loading dose of oral perifosine 4 times a day for 4-8 doses followed by a daily maintenance dose. Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating loading doses and maintenance doses of perifosine until the maximum tolerated dose (MTD) of each is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxic effects.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed locally unresectable or metastatic malignancy that is considered incurable
- •Refractory to further treatment with known forms of effective therapy
- •No clinically active CNS metastasis
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •WBC at least 4,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin normal
- •SGOT no greater than 2.5 times upper limit of normal
- •Creatinine normal OR
- •Creatinine clearance at least 60 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 6 months after study participation
- •Maintaining a reasonable state of nutrition consistent with weight maintenance
- •No recent history of weight loss greater than 10% of current body weight
- •No frequent vomiting/poor alimentation
- •No other serious concurrent medical illness that would preclude study therapy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent immunotherapy
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •No concurrent hormonal therapy
- •Patients who have progressive disease while being treated with LHRH agonists, antiestrogens, or antitestosterones for at least 3 months may remain on these agents if in their best interest
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy
- •No concurrent radiotherapy
- •See Disease Characteristics
- •At least 21 days since prior major surgery
排除标准
- 未提供
研究者
研究点 (1)
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