NCT00572182终止1 期
A Phase I Study of MK-0752 in Pediatric Patients With Recurrent or Refractory CNS Malignancies
Pediatric Brain Tumor Consortium24 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2008年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 33
- 试验地点
- 24
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
RATIONALE: MK0752 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of MK0752 in treating young patients with recurrent or refractory CNS cancer.
详细描述
OBJECTIVES:
Primary
- To estimate the maximum tolerated dose (MTD) and recommended phase II dose of MK0752 administered for 3 consecutive days of every 7 days in 28 day courses to young patients with recurrent or refractory CNS malignancies (Dosing regimen 1 - closed to accrual 2/23/2010).
- To estimate the MTD and recommend a phase II dose of MK0752 administered once weekly in 28 day courses to young patients with recurrent or refractory CNS malignancies (Dosing regimen 2).
- To compared the MK0752 systemic exposure attained with each dosage level on the different dosing regimens.
Secondary
- To characterize the pharmacokinetics of MK0752.
- To document and describe toxicities associated with MK0752.
- To preliminarily define the antitumor activity of MK0752 within the confines of a phase I setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed primary CNS tumor
- •Patients with intrinsic brain stem tumors do not require histologic verification, but must have radiographic evidence of progression
- •Recurrent disease or refractory to standard therapy
- •No histologically benign brain tumors (e.g., low-grade glioma)
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status (PS) or Lansky PS 60-100%
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Absolute neutrophil count ≥ 1,000/μL
- •Platelet count ≥ 100,000/μL (unsupported)
- •Hemoglobin ≥ 8 g/dL (RBC transfusions allowed)
- •Creatinine clearance OR glomerular filtration rate ≥ 70 mL/min OR serum creatinine based on age as follows:
- •0.8 mg/dL (≤ 5 years of age)
- •1.0 mg/dL (> 5 to ≤ 10 years of age)
- •1.2 mg/dL (> 10 to ≤ 15 years of age)
- •1.5 mg/dL (> 15 years of age)
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
- •ALT ≤ 2.5 times ULN for age
- •Albumin ≥ 2.5 g/dL
- •Sodium, potassium, magnesium, and calcium normal
- •Patients with neurological deficits are eligible provided these deficits are stable for ≥ 2 weeks prior to study registration
- •No clinically significant systemic illness (e.g., serious infection or significant cardiac, pulmonary, hepatic, or other organ dysfunction) that would compromise the patient's ability to tolerate study therapy or would likely interfere with the study procedures or results
- •No known hypersensitivity to MK0752
- •PRIOR CONCURRENT THERAPY:
- •Recovered from the acute toxic effects of all prior therapy
- •At least 3 weeks since prior myelosuppressive anticancer chemotherapy (6 weeks for nitrosoureas)
- •At least 7 days since prior investigational or biologic agents
- •At least 3 weeks since prior investigational or biologic agents that have a prolonged half-life or for which the patient has experienced ≥ grade 2 myelosuppression in the treatment course preceding discontinuation of therapy
- •At least 3 half lives since prior monoclonal antibody therapy
- •At least 6 months since prior total body irradiation or craniospinal radiotherapy
- •At least 6 weeks since other prior substantial bone marrow irradiation
- •At least 2 weeks since prior local palliative radiotherapy (small volume)
- •At least 6 months since prior allogeneic bone marrow transplantation (BMT)
- •No evidence of active graft versus host disease
- •At least 3 months since prior autologous BMT or stem cell transplantation
- •At least 7 days since prior hematopoietic growth factors (filgrastim [G-CSF], sargramostim [GM-CSF], or erythropoietin) (14 days for long-acting formulations)
- •No prior MK0752
- •No concurrent enzyme-inducing anticonvulsant drugs (EIACDs)
- •No other concurrent anticancer or investigational drug therapy
- •Concurrent dexamethasone allowed provided patient is on a stable or decreasing dose for ≥ 2 weeks prior to study registration
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose
时间窗: First 28 days of treatment
MK0752 systemic exposure
时间窗: Day 1 of course 1
Serial blood samples for pharmacokinetic studies of MK-0752 will be collected with the first dose of course 1 at pre-specified times.
次要结局
- Pharmacokinetics(Day 1 of course 1)
- Toxicity(From day 1 of treatment until off study)
- Objective response rate(End of courses 2, 4, 6 and at the end of treatment)
研究者
研究点 (24)
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