NCT00036959已完成1 期
Phase I Trial and Pharmacokinetic Study of ABT-751, an Orally Bioavailable Tubulin Binding Agent, on a 7 Day and 21 Day Dosing Schedule in Pediatric Patients With Refractory Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 6
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as ABT-751, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects of ABT-751 in treating young patients with refractory solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and dose-limiting toxic effects of ABT-751 administered daily for 7 days every 21 days or daily for 21 days every 28 days in children with refractory solid tumors.
- Determine the toxicity spectrum of these regimens in these patients.
- Determine the pharmacokinetics of these regimens in these patients.
- Evaluate the pharmacodynamics of this drug by measuring the fraction of tubulin that is polymerized in the peripheral blood mononuclear cells of these patients before and after receiving this drug.
Secondary
- Quantify responses in patients treated with these regimens.
- Assess the effect of this drug on tumor vascularity and tumor blood flow using dynamic enhanced MRI in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed solid tumor*, including, but not limited to, the following:
- •Rhabdomyosarcoma
- •Other soft tissue sarcomas
- •Ewing's sarcoma family of tumors
- •Osteosarcoma
- •Neuroblastoma
- •Wilms' tumor
- •Hepatic tumors
- •Germ cell tumors
- •Primary brain tumors
- •Brain stem or optic gliomas (histological confirmation may be waived if a biopsy has not been performed) NOTE: *Closed to accrual for all diagnoses except neuroblastoma as of 4/16/05
- •Relapsed after or failed to respond to frontline standard therapy and no other standard treatment options (e.g., surgery, radiotherapy, chemotherapy, or any combination of these modalities) exist
- •Measurable or evaluable disease* NOTE: *Not required for patients with neuroblastoma
- •No CNS tumor with motor or sensory deficits that would obscure the study assessment of sensory neuropathy
- •PATIENT CHARACTERISTICS:
- •18 and under
- •Performance status:
- •Lansky 60-100% (age 10 and under)
- •Karnofsky 60-100% (age 11 to 18)
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •ALT and AST no greater than 2.5 times ULN (5 times ULN for patients treated after the maximum tolerated dose is determined)
- •No clinically significant hepatic dysfunction
- •Creatinine normal for age OR
- •Creatinine clearance at least 60 mL/min
- •No clinically significant renal dysfunction
- •Cardiovascular:
- •LVEF normal by echocardiogram
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No allergy to sulfa-containing medications
- •No clinically significant unrelated systemic illness (e.g., other organ dysfunction) that would preclude study participation
- •No serious infection
- •No preexisting grade 2 or greater sensory or motor neuropathy
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 months since prior bone marrow transplantation
- •At least 72 hours since prior interleukin-11
- •At least 72 hours since prior colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) except epoetin alfa
- •No concurrent growth factors (e.g., GM-CSF) except epoetin alfa
- •Concurrent G-CSF allowed if neutropenia lasts longer than 5 days OR if the patient experiences confirmed septicemia associated with neutropenia
- •No concurrent immunotherapy
- •No concurrent interleukin-11
- 另有 17 项未显示
排除标准
- 未提供
研究者
研究点 (6)
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