NCT00293410已完成1 期
Phase I Dose-Escalation Trial of Clofarabine Followed by Escalating Doses of Fractionated Cyclophosphamide in Adults and Children With Relapsed or Refractory Acute Leukemias
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2005年11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
- 入组人数
- 70
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as clofarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine and cyclophosphamide in treating patients with relapsed or refractory acute leukemia, chronic myelogenous leukemia, or myeloproliferative disorders.
详细描述
OBJECTIVES:
Primary
- Determine the feasibility and tolerability of administering clofarabine and fractionated cyclophosphamide in patients with relapsed or refractory acute leukemia, chronic myelogenous leukemia, or high-risk myeloproliferative disorders
- Determine the maximum tolerated dose of clofarabine and fractionated cyclophosphamide in these patients.
- Determine the toxic effects of these drugs in these patients.
Secondary
- Obtain preliminary data of biologic and pharmacodynamic effects of this regimen on marrow and circulating leukemic blasts in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed leukemia or myeloproliferative disorders, including 1 of the following:
- •Acute myeloid leukemia (AML) of any subtype
- •Treatment-related AML OR AML evolving from myeloproliferative disorders (MPD) or transformed from myelodysplastic syndrome
- •Acute lymphocytic leukemia
- •Acute progranulocytic leukemia
- •Must not be eligible for arsenic or retinoic acid therapy
- •Chronic myelogenous leukemia in accelerated phase or blast crisis
- •High-risk MPD, including any of the following:
- •Myelofibrosis
- •Chronic myelomonocytic leukemia with 5%-19% blasts
- •Relapsed or refractory juvenile myelomonocytic leukemia
- •Relapsed and/or refractory disease with progressive disease since last therapy
- •No more than 3 prior induction regimens with cytotoxic agents for adults
- •Must be in second relapse for patients < 21 years of age
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2 (for adults) OR Lansky 50-100% (for pediatric patients)
- •Bilirubin ≤ 1.5 mg/dL (may be elevated due to hemolysis in adult patients)
- •AST and ALT ≤ 5 times upper limit of normal
- •Creatinine ≤ 2.0 mg/dL (for adults)
- •Normal renal function (for pediatric patients)
- •Cardiac function normal as measured by MUGA scan or echocardiogram
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception during and for at least 6 months after completion of study treatment
- •HIV negative
- •No active graft-versus-host disease ≥ grade 2
- •No active, uncontrolled infection
- •No unstable CT scans of the lungs, sinuses, or abdomen within the past 4 weeks
- •No arrhythmias (other than atrial flutter or fibrillation) requiring medication
- •No dyspnea at rest or with minimal exertion
- •No uncontrolled congestive heart failure
- •No myocardial infarction within the past 3 months
- •No history of severe coronary artery disease
- •No other significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance or interfere with consent, study participation, follow up, or interpretation of study results
- •PRIOR CONCURRENT THERAPY:
- •Must have recovered from all acute toxic effects from prior treatment
- •More than 30 days since prior investigational cytotoxic agents
- •At least 3 days since prior azacitidine, thalidomide, hydroxyurea, imatinib mesylate, or interferon
- •At least 1 week since prior growth factors except epoetin alfa
- •More than 3 weeks since any other prior anticancer therapy
- •No concurrent chemotherapy, radiotherapy, or immunotherapy
- •No other concurrent anticancer investigational or commercial agents
- •No routine prophylactic use of a colony-stimulating factor (filgrastim [G-CSF] or sargramostim [GM-CSF])
- •Therapeutic use of colony-stimulating factors may be considered at the discretion of the investigator
- •No prolonged use of corticosteroids to prevent or treat emesis or as a chemotherapeutic agent
排除标准
- 未提供
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
Clofarabine, Cytarabine, and G-CSF in Treating Patients With Myelodysplastic SyndromesMyelodysplastic SyndromesNCT00503880University of Nebraska2
已完成
1 期
Clofarabine, Cytarabine, and G-CSF in Treating Patients With Relapsed or Refractory Acute Myeloid LeukemiaAdult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Promyelocytic Leukemia (M3)Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)Recurrent Adult Acute Myeloid LeukemiaAcute Myeloid LeukemiaNCT00602225University of Washington50
已完成
1 期
Combination Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute LeukemiaLeukemiaNCT00462787Memorial Sloan Kettering Cancer Center23
Unknown
2 期
Fludarabine, Cyclophosphamide, and Thalidomide in Treating Patients With Angioimmunoblastic T-Cell LymphomaLymphomaNCT00958854Cancer Research UK37
已完成
2 期
Fludarabine and Alemtuzumab or Cyclophosphamide Followed by Peripheral Blood Stem Cell Transplant or Alemtuzumab in Treating Patients With Advanced or Progressive Chronic Lymphocytic LeukemiaLeukemiaNCT00462332Gruppo Italiano Malattie EMatologiche dell'Adulto86