A Phase I Study of Triapine and Cytarabine in 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 cytarabine use different ways to stop cancer cells from dividing so they stop growing or die. 3-AP may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth and may help cytarabine kill more cancer cells by making them more sensitive to the drug.
PURPOSE: Phase I trial to study the effectiveness of combining cytarabine with 3-AP in treating patients who have relapsed or refractory hematologic cancer.
详细描述
OBJECTIVES:
- Determine the feasibility, tolerability, and toxic effects of 3-AP in combination with cytarabine in patients with hematologic malignancies.
- Determine the maximum tolerated dose and phase II dose of cytarabine in this regimen in these patients.
- Determine the biological effects of 3-AP and its interaction with cytarabine in these patients.
OUTLINE: This is a pilot, dose-escalation study of cytarabine.
Patients receive 3-AP IV over 6 hours followed by cytarabine IV over 18 hours on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a response may receive an additional course as consolidation therapy.
Cohorts of 3-6 patients receive escalating doses of cytarabine 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. Once the MTD is determined, an additional 10 patients receive treatment at that dose.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 1 of the following hematologic malignancies:
- •Acute myeloid leukemia
- •Acute lymphoblastic leukemia
- •Chronic myelogenous leukemia (CML)
- •CML in blast crisis
- •Chronic lymphocytic leukemia
- •High-risk* myelodysplastic syndromes, including the following:
- •Refractory anemia with excess blasts (RAEB)
- •RAEB in transformation
- •Chronic myelomonocytic leukemia NOTE: *High-risk myelodysplasia defined as having an International Performance Scoring System score of at least 1.5, based on adverse cytogenetics, greater than 10% blasts in marrow, and cytopenias in at least 2 lineages
- •Relapsed or refractory disease
- •Ineligible for higher priority protocols
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •More than 2 months
- •Hematopoietic
- •See Disease Characteristics
- •Bilirubin no greater than 2.0 mg/dL (unless considered due to malignancy)
- •ALT or AST no greater than 3 times upper limit of normal
- •Chronic hepatitis allowed
- •Creatinine no greater than 2.0 mg/dL (unless considered due to malignancy)
- •Cardiovascular
- •No myocardial infarction within the past 3 months
- •No symptomatic coronary artery disease
- •No arrhythmias (other than atrial fibrillation or flutter) requiring treatment
- •No uncontrolled congestive heart failure
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Concurrent infections under active treatment with and controlled by antibiotics allowed
- •No other concurrent life-threatening illness
- •No mental deficit or psychiatric history that would preclude giving informed consent or complying with protocol
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •At least 1 week since prior growth factors, including the following:
- •Epoetin alfa
- •Filgrastim (G-CSF)
- •Sargramostim (GM-CSF)
- •Interleukin-3
- •Interleukin-11
- •No concurrent anticancer immunotherapy
- •Chemotherapy
- •At least 72 hours since prior hydroxyurea
- •Recovered from prior chemotherapy
- •No other concurrent anticancer chemotherapy
- •Endocrine therapy
- •Not specified
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排除标准
- 未提供