Fludarabine, Carboplatin, and Topotecan in Treating Patients With Relapsed/Refractory Acute Leukemia or Advanced Myelodysplastic Syndrome
Phase I Study of Fludarabine, Carboplatin, and Topotecan for Patients With Relapsed/Refractory Acute Leukemia and Advanced Myelodysplastic Syndromes
RATIONALE: Drugs used in chemotherapy 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 fludarabine, carboplatin, and topotecan in treating patients who have relapsed or refractory acute leukemia or advanced myelodysplastic syndrome.
研究概览
详细说明
OBJECTIVES: I. Determine the maximum tolerated dose of topotecan when administered with carboplatin and fludarabine in patients with refractory or relapsed acute leukemia or advanced myelodysplastic syndrome. II. Determine treatment related and dose limiting toxicities of this regimen in these patients. III. Determine the antileukemia activity of this regimen in these patients. IV. Correlate treatment related toxicities with steady state levels of topotecan in these patients.
OUTLINE: This is a dose escalation study of topotecan. Patients receive carboplatin IV continuously and fludarabine IV over 30 minutes on days 1-5, then topotecan IV continuously on days 6-8. Patients with residual leukemia in the bone marrow at day 15 may receive a second induction course. Patients who achieve partial or complete remission after 1-2 induction courses receive 1 consolidation course of fludarabine, carboplatin, and topotecan beginning 4-8 weeks after recovery from induction therapy. Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The first 3 patients do not receive any topotecan. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose limiting toxicity. Patients are followed monthly for 6 months.
PROJECTED ACCRUAL: A total of 6-15 patients will be accrued for this study within 15-21 months.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
-
-
Ohio
-
Cleveland、Ohio、美国、44106-5065
- Ireland Cancer Center at University Hospitals Case Medical Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS: Diagnosis of one of the following: Acute myelogenous leukemia (M0-M7) M3 must have received tretinoin as part of induction or salvage chemotherapy No greater than 2 prior intensive induction regimens Acute lymphocytic leukemia (L1 or L2) in first or second relapse Circulating blasts in blood or greater than 5% blasts in bone marrow No greater than 2 prior intensive induction regimens Chronic myelogenous leukemia in myeloid or lymphoid blast crisis Initial diagnosis OR No greater than 2 prior intensive induction regimens Acute myelogenous leukemia secondary to prior myelodysplastic syndrome or prior cytotoxic therapy No greater than 2 prior intensive induction regimens Myelodysplastic syndrome (must be neutropenic (absolute neutrophil count less than 500/mm3) or platelet or red cell transfusion dependent) Refractory anemia with excess blasts (RAEB) OR RAEB in transformation OR Chronic myelomonocytic leukemia Relapse after greater than 3 months since prior autologous stem cell transplant allowed No relapse after allogeneic bone marrow transplant No active CNS leukemia
PATIENT CHARACTERISTICS: Age: 12 and over Performance status: ECOG 0-3 Life expectancy: At least 4 weeks Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2.0 mg/dL AST and ALT less than 3 times upper limit of normal Renal: Creatinine clearance at least 50 mL/min Cardiovascular: No symptomatic cardiac disease No active ischemic heart disease No poorly controlled congestive heart failure No myocardial infarction within past 6 months Cardiac ejection fraction at least 40% Pulmonary: No symptomatic pulmonary disease No symptomatic restrictive or obstructive lung disease Other: Not pregnant or nursing Fertile patients must use effective contraception No active infections, unless receiving antibiotics and clinically stable Fever caused by tumor allowed HIV negative No other active malignant disease Curatively treated prior malignancies allowed No severe neurologic disease
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 5 days since prior hematopoietic growth factors Chemotherapy: See Disease Characteristics At least 24 hours since prior hydroxyurea At least 2 weeks since other prior cytotoxic anticancer therapy Prior carboplatin, fludarabine, or topotecan allowed Endocrine therapy: Concurrent corticosteroids allowed Radiotherapy: Not specified Surgery: Not specified
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Determine the maximum tolerated dose of topotecan when administered with carboplatin and fludarabine.
大体时间:Patients are followed monthly for 6 months.
|
Patients are followed monthly for 6 months.
|
合作者和调查者
调查人员
- 学习椅:Brenda W. Cooper, MD、Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
出版物和有用的链接
一般刊物
- Cooper BW, Ksenich P, Koc O, et al.: A phase I and pharmacodynamic study of fludarabine, carboplatin, and topotecan (FCT) for relapsed/refractory acute leukemia (RAL) and advanced myelodysplastic syndromes (MDS). [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1207, 2001.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
- 顽固性贫血伴原始细胞过多
- 转化中原始细胞过多的难治性贫血
- 慢性粒单核细胞白血病
- 既往治疗过的骨髓增生异常综合征
- 继发性骨髓增生异常综合征
- 继发性急性髓性白血病
- 儿童骨髓增生异常综合征
- 复发性成人急性髓性白血病
- 成人急性红细胞白血病 (M6)
- 成人急性巨核细胞白血病 (M7)
- 成人急性低分化髓性白血病 (M0)
- 成人急性单核细胞白血病 (M5a)
- 成人急性单核细胞白血病 (M5b)
- 成熟型成人急性成髓细胞白血病 (M2)
- 未成熟的成人急性成髓细胞白血病 (M1)
- 成人急性粒单核细胞白血病 (M4)
- 母细胞期慢性粒细胞白血病
- 复发性慢性粒细胞白血病
- 复发性成人急性淋巴细胞白血病
- 复发性儿童急性淋巴细胞白血病
- L1成人急性淋巴细胞白血病
- L2成人急性淋巴细胞白血病
- L1 儿童急性淋巴细胞白血病
- L2儿童急性淋巴细胞白血病
- 复发性儿童急性髓性白血病
- 儿童急性红白血病 (M6)
- 儿童急性巨核细胞白血病 (M7)
- 儿童急性低分化髓性白血病 (M0)
- 儿童急性早幼粒细胞白血病 (M3)
- 成人急性早幼粒细胞白血病 (M3)
- 未成熟的儿童急性成髓细胞白血病 (M1)
- 儿童急性成髓细胞白血病成熟期 (M2)
- 儿童急性粒单核细胞白血病 (M4)
- 儿童急性单核细胞白血病 (M5a)
- 儿童急性单核细胞白血病 (M5b)
其他相关的 MeSH 术语
其他研究编号
- CWRU1998
- P30CA043703 (美国 NIH 拨款/合同)
- CWRU-1998
- CWRU-059812
- NCI-G00-1732
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
carboplatin的临床试验
-
IO BiotechMerck Sharp & Dohme LLC完全的
-
Virginia Commonwealth UniversityNational Cancer Institute (NCI)撤销IIIA期非小细胞肺癌 | IIIB 期非小细胞肺癌 | 鳞状细胞肺癌 | 肺腺癌 | 大细胞肺癌 | IIA期非小细胞肺癌 | IIB 期非小细胞肺癌
-
Children's Oncology GroupNational Cancer Institute (NCI)完全的