506U78 in Treating Patients With Hematologic Cancer and Kidney or Liver Impairment
A Phase I Study of Compound 506U78 (NSC #686673) in Patients With Hematologic Malignancies and Renal or Hepatic Impairment
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of 506U78 in treating patients who have hematologic cancer and kidney or liver impairment.
研究概览
详细说明
OBJECTIVES: I. Determine the maximum tolerated dose of 506U78 in patients with hematologic malignancies and renal or hepatic impairment. II. Establish dosing guidelines for this drug in this patient population. III. Determine the toxicities and pharmacokinetics of this drug in these patients.
OUTLINE: Patients are stratified into 5 groups according to renal and hepatic function: Group 1: Normal renal function and normal hepatic function Group 2: Moderate renal impairment and normal hepatic function Group 3: Severe renal impairment and normal hepatic function Group 4: End stage renal impairment and normal hepatic function Group 5: Normal renal function and moderate hepatic impairment Group 1: Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Groups 2-5: Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Dose escalation occurs independently in each of the treatment groups. Cohorts of 3-6 patients receive escalating doses of 506U78 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 toxicities. Treatment repeats every 4 weeks for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression.
PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Illinois
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Chicago、Illinois、美国、60637-1470
- University of Chicago Cancer Research Center
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Iowa
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Iowa City、Iowa、美国、52242-1009
- Holden Comprehensive Cancer Center at the University of Iowa
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North Carolina
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Winston-Salem、North Carolina、美国、27157-1082
- Comprehensive Cancer Center at Wake Forest University
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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: Histologically confirmed hematologic malignancy that has failed standard therapy or for which no standard therapy exists, including, but not limited to, the following: Acute lymphocytic leukemia Acute myelogenous leukemia Chronic lymphocytic leukemia Chronic myelogenous leukemia Multiple myeloma Non-Hodgkin's lymphoma Hodgkin's disease No history of CNS disease, including carcinomatous meningitis
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CTC 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin: Groups 1-4: Less than 1.5 times upper limit of normal (ULN) Group 5: 1.5-4 times ULN Renal: Creatinine clearance: Groups 1 and 5: Greater than 50 mL/min Group 2: 30-50 mL/min Group 3: Less than 30 mL/min Group 4: Less than 30 mL/min, requiring dialysis Neurologic: No history of grade 2 peripheral neuropathy No history of seizure disorder No history of neurologic dysfunction Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy (e.g., interferon, monoclonal antibodies) No concurrent interleukin-11 for treatment or prevention of thrombocytopenia No concurrent prophylactic colony stimulating factors Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for melphalan, carmustine, or mitomycin) At least 72 hours since prior hydroxyurea No prior 506U78 No other concurrent chemotherapy Endocrine therapy: At least 72 hours since prior glucocorticoids Concurrent continuation of steroids for adrenal failure allowed No concurrent hormones except for nondisease related conditions (e.g., insulin for diabetes) No concurrent dexamethasone or other steroidal antiemetics Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent palliative radiotherapy No concurrent whole brain irradiation for documented CNS disease Surgery: Not specified Other: At least 72 hours since prior aspirin
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)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Compound 506U78
Compound 506U78 will be administered intravenously over 2 hours on days 1, 3 and 5 of each 28 day treatment cycle.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Maximum tolerated dose
大体时间:Up to 6 months
|
Up to 6 months
|
合作者和调查者
调查人员
- 学习椅:Todd M. Zimmerman, MD、University of Chicago
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
- 原发性骨髓纤维化
- 复发性 3 级滤泡性淋巴瘤
- 复发性成人弥漫性大细胞淋巴瘤
- 复发性成人免疫母细胞大细胞淋巴瘤
- 复发性成人伯基特淋巴瘤
- 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
- 原发性系统性淀粉样变性
- 复发性成人急性髓性白血病
- 复发性成人霍奇金淋巴瘤
- 复发性成人弥漫性小裂细胞淋巴瘤
- 复发性成人弥漫性混合细胞淋巴瘤
- 复发性慢性粒细胞白血病
- 华氏巨球蛋白血症
- III期多发性骨髓瘤
- 复发性 1 级滤泡性淋巴瘤
- 复发性 2 级滤泡性淋巴瘤
- 复发性边缘区淋巴瘤
- 复发性小淋巴细胞淋巴瘤
- 黏膜相关淋巴组织结外边缘区B细胞淋巴瘤
- 淋巴结边缘区B细胞淋巴瘤
- 脾边缘区淋巴瘤
- 复发性成人淋巴母细胞淋巴瘤
- 复发性套细胞淋巴瘤
- 难治性慢性淋巴细胞白血病
- 复发性皮肤 T 细胞非霍奇金淋巴瘤
- 复发性成人 T 细胞白血病/淋巴瘤
- 间变性大细胞淋巴瘤
- 复发性蕈样肉芽肿/Sezary 综合征
- 难治性多发性骨髓瘤
- 复发性成人急性淋巴细胞白血病
- 真性红细胞增多症
- 原发性血小板增多症
- 难治性毛细胞白血病
- 幼淋巴细胞白血病
其他相关的 MeSH 术语
其他研究编号
- CALGB-69803
- U10CA031946 (美国 NIH 拨款/合同)
- CLB-69803
- CDR0000067483 (注册表标识符:NCI Physician Data Query)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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