Lenalidomide in Treating Young Patients With Relapsed or Refractory Solid Tumors or Myelodysplastic Syndromes
Phase I Study of CC-5013 (Lenalidomide NSC# 703813) in Pediatric Patients With Relapsed/Refractory Solid Tumors or Myelodysplastic Syndrome
研究概览
地位
条件
干预/治疗
详细说明
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose and recommended phase II dose of lenalidomide in pediatric patients with relapsed or refractory solid tumors.
II. Determine the toxic effects of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients.
SECONDARY OBJECTIVES:
I. Determine, preliminarily, the feasibility of administering this drug to pediatric patients with relapsed or refractory myelodysplastic syndromes.
II. Determine, preliminarily, the antitumor activity of this drug in both patient populations.
III. Determine immunologic changes in patients treated with this drug.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to diagnosis (solid tumor vs myelodysplastic syndromes [MDS]).
Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients with solid tumors receive escalating doses of lenalidomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients with MDS receive a fixed dose (do not undergo dose escalation) of lenalidomide. After completion of study treatment, patients are followed annually.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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California
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Arcadia、California、美国、91006-3776
- COG Phase I Consortium
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Diagnosis of 1 of the following:
Histologically confirmed solid tumor
- No brain tumors
Myelodysplastic syndromes (MDS)
- No refractory anemia with excess blasts in transformation or other forms of acute myeloid leukemia (AML)
- No FAB diagnosis of refractory anemia with excess blasts in transition and other forms of AML
- Newly diagnosed MDS with chromosome 5q abnormalities
- Relapsed or refractory disease including relapse after stem cell transplantation
- Measurable or evaluable disease (solid tumor patients only)
- No known curative or life-prolonging therapy exists
- No bone marrow involvement by tumor (solid tumor patients only)
- No CNS tumors
- Performance status - Karnofsky 50-100% (for patients > 10 years of age)
- Performance status - Lansky 50-100% (for patients ≤ 10 years of age)
- Absolute neutrophil count ≥ 1,000/mm^3 (for patients with solid tumors)
Platelet count ≥ 100,000/mm^3 (30,000 for patients with MDS)
- Only patients with MDS may receive transfusions to support platelet counts
- Hemoglobin ≥ 8.0 g/dL (transfusions allowed)
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT ≤ 110*
- Albumin ≥ 2 g/dL
- Creatinine clearance OR radioisotope glomerular filtration rate ≥ 70 mL/min
Creatinine based on age as follows:
- Creatinine ≤ 0.8 mg/dL (for patients ≤ 5 years of age)
- Creatinine ≤ 1 mg/dL (for patients 6 to 10 years of age)
- Creatinine ≤ 1.2 mg/dL (for patients 11 to 15 years of age)
- Creatinine ≤ 1.5 mg/dL (for patients over 15 years of age)
- No parent or sibling with a known history of venous thrombosis before the age of 50 OR arterial thrombosis before the age of 40
- No thromboembolic event except catheter-related thrombosis
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-method contraception 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment
- Body surface area ≥ 0.4m^2
- No uncontrolled infection
- No active graft-vs-host disease from prior stem cell transplant or rescue
- Recovered from prior immunotherapy
- At least 1 week since prior biologic agents
- At least 1 week since prior hematologic growth factors (2 weeks for pegfilgrastim)
- At least 3 months since prior stem cell transplant or rescue (without total body irradiation [TBI])
- Prior thalidomide allowed
- No other concurrent immunotherapy
- No other concurrent biologic therapy
- More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered
- No concurrent chemotherapy
- Concurrent dexamethasone allowed provided the dose has been either decreasing or stable for the past 7 days
- See Biologic therapy
- Recovered from prior radiotherapy
- At least 2 weeks since prior local palliative (small port) radiotherapy
- At least 6 months since prior TBI, craniospinal radiotherapy, or radiotherapy to ≥ 50% of the pelvis
- At least 6 weeks since other prior substantial bone marrow radiotherapy
- No concurrent radiotherapy
- No other concurrent investigational drugs or agents
- No other concurrent anticancer agents
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Treatment (lenalidomide)
Patients receive oral lenalidomide once daily on days 1-21.
Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
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口头给予
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Maximum tolerated dose of lenolidomide defined as the maximum dose at which fewer than one-third of patients experience DLT
大体时间:28 days
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Graded using the CTCAE version 3.0.
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28 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Overall response assessed using RECIST criteria
大体时间:Up to 30 days after completion of study treatment
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A patient will be considered to have responded if she or he demonstrates either a bone marrow or cytogenetic response.
Each patient will be classified according to the maximum response of the two criteria, where the classification from maximum to minimum will be: CR, PR or nonresponse.
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Up to 30 days after completion of study treatment
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Adverse events defined using the NCI CTCAE version 3.0
大体时间:Up to 30 days after completion of study treatment
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Up to 30 days after completion of study treatment
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合作者和调查者
调查人员
- 首席研究员:Stacey Berg、COG Phase I Consortium
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- NCI-2012-01820 (注册表标识符:CTRP (Clinical Trial Reporting Program))
- U01CA097452 (美国 NIH 拨款/合同)
- COG-ADVL0319
- NCI-P6553
- CDR0000413700
- NCI-06-C-0052
- ADVL0319 (其他标识符:CTEP)
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
来那度胺的临床试验
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University of Alabama at BirminghamJanssen Scientific Affairs, LLC; Amgen完全的