NCT00022451已完成1 期
A Phase I Trial and Pharmacokinetic Study of R115777 in Pediatric Patients With Refractory Leukemia
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 61
研究概览
简要总结
RATIONALE: Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase I trial to study the effectiveness of tipifarnib in treating young patients who have refractory leukemia.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and toxicity profile of tipifarnib in pediatric patients with refractory leukemia.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the toxicity profile of this drug in these patients.
Secondary
- Analyze the gene expression profile of leukemic blasts from these patients before and after treatment with this drug.
- Determine circulating levels of nerve growth factor and correlate these levels with clinical neurotoxicity from this drug 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 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed acute lymphoblastic leukemia, acute nonlymphoblastic leukemia, juvenile myelomonocytic leukemia (JMML), or chronic myelogenous leukemia (CML) in blast crisis
- •Refractory to standard curative therapy
- •Acute promyelocytic leukemia refractory to tretinoin and arsenic trioxide
- •Philadelphia chromosome-positive CML refractory to imatinib mesylate
- •Greater than 25% blasts in bone marrow (M3 bone marrow) except for patients with JMML
- •Active extramedullary disease allowed
- •No active leptomeningeal leukemia
- •PATIENT CHARACTERISTICS:
- •21 and under
- •Performance status:
- •Karnofsky 50-100% (over 10 years of age)
- •Lansky 50-100% (10 years of age and under)
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not required to be normal
- •Bilirubin normal
- •SGPT and SGOT normal
- •No significant hepatic dysfunction
- •No grade 3 or 4 liver function test results within the past month
- •Creatinine normal OR
- •Creatinine clearance at least 60 mL/min
- •No significant renal dysfunction
- •Cardiovascular:
- •No significant cardiac dysfunction
- •No significant pulmonary dysfunction
- •Neurologic:
- •No history of grand mal seizures grade 3 or greater except febrile seizures
- •No persistent sensory or motor neuropathy greater than grade 2
- •No clinically significant unrelated systemic illness
- •No serious infection
- •No organ dysfunction that would preclude study participation
- •No requirement for total parenteral nutrition
- •No known allergy to azoles (e.g., clotrimazole, fluconazole, ketoconazole, voriconazole)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 1 week since prior colony-stimulating factor therapy (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) except epoetin alfa
- •At least 3 months since prior myeloablative therapy followed by bone marrow or stem cell transplantation
- •No concurrent immunotherapy
- •No concurrent GM-CSF or interleukin-11
- •Chemotherapy:
- •At least 2 weeks since prior chemotherapy
- •No concurrent intrathecal chemotherapy
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •At least 1 week since prior corticosteroids
- 另有 11 项未显示
排除标准
- 未提供
研究者
研究点 (61)
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