A Phase I Study Of VNP40101M And Cytarabine For Patients With Hematologic Malignancies
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, such as VNP40101M and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of combining VNP40101M with cytarabine in treating patients who have hematologic malignancies, including myelodysplastic syndrome or relapsed, refractory, or untreated leukemia.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of VP40101M when administered with cytarabine in patients with hematologic malignancies.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is an open-label, dose-escalation study of VNP40101M.
Patients receive cytarabine IV over 24 hours on days 1-4 for patients under 65 years of age OR on days 1-3 for patients 65 years of age and over. Patients also receive VNP40101M IV over 15-60 minutes on day 2. Treatment repeats every 4 weeks for up to 3 courses (in patients with responding disease) in the absence of disease progression or unacceptable toxicity. Patients with a continued response may receive additional courses at the discretion of the investigator.
Cohorts of 3-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 10 patients may receive treatment at the MTD.
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:
- •Diagnosis of leukemia or myelodysplastic syndromes (MDS) meeting criteria for 1 of the following:
- •Relapsed or refractory leukemia for which there is no standard therapy anticipated to result in a durable remission
- •Acute myeloid leukemia
- •Acute lymphocytic leukemia
- •Chronic myelogenous leukemia
- •In blast crisis
- •Untreated leukemia and standard therapy is refused
- •Any of the following poor-risk MDS:
- •Refractory anemia with excess blasts (RAEB)
- •RAEB in transformation
- •Chronic myelomonocytic leukemia
- •CNS leukemia allowed
- •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)
- •ALT or AST no greater than 3 times ULN
- •Chronic hepatitis allowed
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular
- •No active heart disease
- •No myocardial infarction within the past 3 months
- •No symptomatic coronary artery disease
- •No arrhythmias uncontrolled by medication
- •No uncontrolled congestive heart failure
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No persistent chronic toxic effects from prior chemotherapy greater than grade 1
- •No uncontrolled active infection
- •Infections under control and under active treatment with antibiotics allowed
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •At least 48 hours since prior hydroxyurea
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
- •At least 2 weeks since prior myelosuppressive cytotoxic agents (in the absence of rapidly progressing disease)
- •No other concurrent standard or investigational treatment for leukemia
- •No concurrent disulfiram
排除标准
- 未提供