Phase I Study To Determine The Safety Of Halofuginone In Patients With A Solid Progressive Tumor
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 3
研究概览
简要总结
RATIONALE: Halofuginone hydrobromide may stop the growth of solid tumors by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of halofuginone hydrobromide in treating patients who have progressive advanced solid tumors.
详细描述
OBJECTIVES:
- Determine the toxicity profile, maximum tolerated dose, and dose-limiting toxic effects of halofuginone hydrobromide in patients with progressive advanced solid tumors.
- Establish a recommended dose of this drug for phase II study.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive oral halofuginone hydrobromide once daily on days 1 and 4-14 of course 1 and on days 1-14 of subsequent courses. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-3 patients receive escalating doses of halofuginone hydrobromide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 20% of patients experience acute dose-limiting toxicity. After the MTD is reached, 6-12 additional patients are treated at dose levels preceding the MTD until the recommended dose for phase II study is determined. The recommended dose for phase II study is defined as the dose preceding the MTD that allows a 90% dose intensity for 2 months with no greater than grade 2 toxicity in 80% of the patients.
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 or cytologically confirmed advanced solid tumor that is not amenable to any clinical improvement by current standard treatments
- •No tumors of the upper digestive tract
- •No clinical signs of CNS involvement
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •ECOG 0-2 OR
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10.0 g/dL
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •AST and ALT no greater than 2.5 times ULN
- •No unstable hepatobiliary disease that would preclude study
- •Creatinine no greater than 1.5 times ULN
- •No unstable renal disease that would preclude study
- •Cardiovascular:
- •No unstable cardiovascular disease (e.g., stroke) that would preclude study
- •No unstable pulmonary disease that would preclude study
- •Gastrointestinal:
- •No digestive disease, including upper gastrointestinal tract, that would hamper absorption
- •No evident/known lactose malabsorption
- •No allergy to components of the study drug
- •No uncontrolled infection
- •No other unstable systemic disease that would preclude study
- •No psychological, familial, sociological, or geographical condition that would preclude compliance
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior anticancer biologic therapy
- •Chemotherapy:
- •At least 4 weeks since prior anticancer chemotherapy
- •Endocrine therapy:
- •Prior anticancer hormonal therapy allowed
- •Radiotherapy:
- •At least 6 weeks since prior radiotherapy
- •No concurrent radiotherapy
- •At least 2 weeks since prior surgery
- •At least 4 weeks since other prior anticancer treatment
- •No other concurrent anticancer agents or investigational therapy
排除标准
- 未提供