A Phase II Study of VNP40101M For Patients With Acute Myelogenous Leukemia Or High-Risk Myelodysplasia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 10
- 主要终点
- Complete response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as VNP40101M and hydroxyurea, work in different ways to stop cancer cells from dividing so they stop growing or die. Hydroxyurea may help VNP40101M kill more cancer cells by making cancer cells more sensitive to the drug.
PURPOSE: This phase II trial is studying how well giving VNP40101M with hydroxyurea works in treating patients with acute myelogenous leukemia or high-risk myelodysplasia.
详细描述
OBJECTIVES:
- Determine the complete response rate to VNP40101M in patients with acute myelogenous leukemia or high-risk myelodysplasia .
- Determine the toxic effects of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is an open-label, multicenter study. Patients are stratified to acute myelogenous leukemia (AML) or high risk myelodysplasia (MDS) patients ≥ 60 years old with no prior treatment vs AML patients any age in first relapse. (AML patients any age in first relapse closed to accrual 06/09/05).
Patients receive VNP40101M IV over 30 minutes once on day 1 (course 1).
Four to five weeks after the first course, patients undergo bone marrow aspiration and biopsy. If the bone marrow is improved but contains residual leukemia, patients receive a second course of VNP40101M (at the same dose as in course 1). If patients achieve complete response (CR), or partial CR after the first or second course, a consolidation course may be given comprising VNP40101M at a reduced dose.
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:
- •Histologically confirmed diagnosis of 1 of the following:
- •Acute myelogenous leukemia (AML), meeting the following criteria:
- •In first relapse after first treatment-induced complete remission (CR) (closed to accrual as of 06/09/05)
- •Duration of first CR less than 12 months
- •No prior treatment for first relapse except hydroxyurea
- •FAB type M0, M1, M2, M4-7
- •No acute promyelocytic leukemia
- •No prior treatment with a standard induction regimen containing cytotoxic agents* (for patients 60 years of age or older)
- •High-risk myelodysplasia, meeting the following criteria:
- •60 years of age and over
- •No prior cytotoxic chemotherapy* except hydroxyurea
- •Prior gemtuzumab ozogamicin allowed
- •High risk defined as International Prognostic Scoring System score ≥ 1.5, defined by cytogenetics, % marrow blasts, and lineage cytopenias NOTE: *Prior low-dose, single-agent cytarabine, decitabine, or azacitidine not considered prior cytotoxic chemotherapy
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Bilirubin ≤ 2.0 mg/dL
- •ALT or AST ≤ 5 times upper limit of normal
- •Chronic hepatitis allowed
- •Creatinine ≤ 2.0 mg/dL
- •Cardiovascular
- •No myocardial infarction within the past 3 months
- •No symptomatic coronary artery disease
- •No uncontrolled arrhythmias
- •No uncontrolled congestive heart failure
- •No other active heart disease
- •No uncontrolled active infection
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Up to 4 leukapheresis procedures allowed during the first 15 days of study treatment
- •Chemotherapy
- •See Disease Characteristics
- •Concurrent additional hydroxyurea (maximum dose of 5 g daily for up to 4 days) allowed between days 4 and 15 of each study course to control elevated blast levels
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
- •Recovered from all prior therapy
- •At least 72 hours since prior anti-leukemic treatment with a non-cytotoxic agent
- •No concurrent disulfiram (Antabuse)
- •No other concurrent anticancer drugs except anagrelide within the first 15 days of study treatment to control elevated platelet counts
- •No other concurrent treatment for leukemia, except hydroxyurea used during study treatment
- 另有 1 项未显示
排除标准
- 未提供
结局指标
主要结局
Complete response rate
Toxic effects
Pharmacokinetics
次要结局
未报告次要终点