NCT00049686已完成1 期
A Phase I Trial Of VNP40101M, A Novel Alkylating Agent, For Patients With Hematologic Malignancies
Vion Pharmaceuticals2 个研究点 分布在 1 个国家开始时间: 2002年4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
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of VNP40101M in treating patients who have relapsed or refractory leukemia or myelodysplastic syndrome.
详细描述
OBJECTIVES:
- Determine the toxic effects of VNP40101M in patients with relapsed or refractory leukemia or poor-risk myelodysplastic syndromes.
- Determine the maximum tolerated dose of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the antitumor effects of this drug in these patients.
OUTLINE: Patients receive VNP40101M IV over 15 minutes once every 4 weeks.
PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Relapsed or refractory leukemia for which no standard therapy is anticipated to result in a durable remission OR
- •Poor-risk myelodysplastic syndromes
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •AST and ALT no greater than 3 times ULN
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular
- •No myocardial infarction within the past 3 months
- •No symptomatic coronary artery disease
- •No uncontrolled arrhythmia
- •No uncontrolled congestive heart failure
- •No uncontrolled active infection
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Prior biologic therapy allowed
- •Chemotherapy
- •At least 2 weeks since prior myelosuppressive cytotoxic chemotherapy in the absence of rapidly progressing disease
- •At least 48 hours since prior hydroxyurea
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Prior radiotherapy allowed
- •Not specified
- •No other concurrent standard or investigational treatment for leukemia
- •No concurrent disulfiram
排除标准
- 未提供
研究者
研究点 (2)
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