NCT00098761已完成1 期
Phase I Study Of Cloretazine (VNP40101M) In Children With Recurrent, Progressive Or Refractory Primary Brain Tumors
Pediatric Brain Tumor Consortium20 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2005年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 20
- 主要终点
- Estimate the maximum tolerated dose
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as VNP40101M, 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 and best dose of VNP40101M in treating young patients with recurrent, progressive, or refractory primary brain tumors.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and dose-limiting toxicity of VNP40101M in pediatric patients with recurrent, progressive, or refractory primary brain tumors.
Secondary
- Determine the pharmacokinetics of this drug and its active metabolite VNP4090CE in these patients.
- Determine the efficacy of this drug in these patients.
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
- — 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 brain tumor, including benign brain tumors (e.g., low-grade glioma)
- •Recurrent or progressive disease OR refractory to standard therapy NOTE: *Patients with intrinsic brain stem or diffuse optic pathway tumors do not require histological confirmation, but must have clinical and/or radiographic evidence of disease progression
- •No bone marrow disease
- •PATIENT CHARACTERISTICS:
- •21 and under
- •Performance status
- •Karnofsky 50-100% (for patients > 16 years of age) OR
- •Lansky 50-100% (for patients ≤ 16 years of age)
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,000/mm^3*
- •Platelet count ≥ 100,000/mm^3*
- •Hemoglobin ≥ 8 g/dL* NOTE: *Unsupported
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •ALT and AST ≤ 2.5 times ULN
- •No overt hepatic disease
- •BUN < 25 mg/dL
- •Creatinine ≤ 1.5 times ULN for age OR
- •Glomerular filtration rate > 70 mL/min
- •No overt renal disease
- •Cardiovascular
- •Shortening fraction ≥ 30% by echocardiogram OR
- •Ejection fraction ≥ 50% by gated radionucleotide study
- •No clinically significant cardiac arrhythmia by EKG
- •No overt cardiac disease
- •DLCO ≥ 60% of predicted
- •Chest X-ray normal (defined as absence of pulmonary infiltrates, pneumonitis, pleural effusion, pulmonary hemorrhage, or fibrosis) AND a resting pulse oximetry reading of > 94% in room air (for patients who cannot perform the DLCO)
- •No overt pulmonary disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Neurologic deficits allowed provided there has been no deficit progression for ≥ 1 week before study entry
- •No uncontrolled infection
- •No known hypersensitivity to polyethylene glycol
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •At least 6 months since prior allogeneic bone marrow or stem cell transplantation
- •At least 3 months since prior autologous bone marrow or stem cell transplantation
- •More than 1 week since prior colony-stimulating factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], or epoetin alfa)
- •At least 3 weeks since prior myelosuppressive anticancer biologic therapy
- •No concurrent routine colony-stimulating factors
- •Chemotherapy
- •At least 3 weeks since prior myelosuppressive anticancer chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •Endocrine therapy
- •Concurrent corticosteroids allowed provided dose is stable or decreasing for ≥ 1 week before study entry
- •Radiotherapy
- •At least 3 months since prior craniospinal irradiation ≥ 18 Gy
- •At least 2 weeks since prior focal irradiation to the primary tumor and/or symptomatic metastatic sites
- 另有 5 项未显示
排除标准
- 未提供
结局指标
主要结局
Estimate the maximum tolerated dose
时间窗: First 6 weeks of therapy
Number of participants with dose limiting toxicities
时间窗: First 6 weeks of therapy
次要结局
- Pharmacokinetics(Day 1 of therapy)
- Tumor response to VNP40101M(Prior to course 3, 5, and 7 and end of therapy)
研究者
研究点 (20)
Loading locations...
相似试验
已完成
2 期
VNP40101M in Treating Patients With Relapsed or Refractory Locally Advanced or Metastatic Small Cell Lung CancerLung CancerNCT00282022Vion Pharmaceuticals87
已完成
1 期
VNP40101M in Treating Patients With Richter Syndrome or Refractory or Relapsed Chronic Lymphocytic Leukemia or Other Lymphoproliferative DisordersLymphomaLeukemiaNCT00304005Vion Pharmaceuticals35
Unknown
2 期
VNP40101M Followed by Cytarabine in Treating Older Patients With Acute Myeloid LeukemiaLeukemiaNCT00354276Vion Pharmaceuticals85
终止
1 期
VNP40101M and Temozolomide in Treating Patients With Progressive or Relapsed Malignant GliomaBrain and Central Nervous System TumorsNCT00516282Northwestern University14
已完成
1 期
Temozolomide and VNP40101M in Treating Patients With Relapsed or Refractory LeukemiasLeukemiaNCT00098436Vion Pharmaceuticals25