17-DMAG in Treating Patients With Metastatic or Unresectable Solid Tumors or Lymphomas
A Phase I Study Of 17-Dimethylaminoethylamino-17-Demethoxygeldanamycin, (17-DMAG) (NSC 707545) In Patients With Advanced Solid Tumors
研究概览
地位
条件
- 粘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
- 复发性成人伯基特淋巴瘤
- 复发性成人弥漫性大细胞淋巴瘤
- 复发性成人弥漫性混合细胞淋巴瘤
- 复发性成人弥漫性小裂细胞淋巴瘤
- 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 3 级滤泡性淋巴瘤
- 复发性套细胞淋巴瘤
- 复发性边缘区淋巴瘤
- 脾边缘区淋巴瘤
- 华氏巨球蛋白血症
- 未明确的成人实体瘤,特定方案
- 间变性大细胞淋巴瘤
- 血管免疫母细胞性T细胞淋巴瘤
- 眼内淋巴瘤
- 复发性成人霍奇金淋巴瘤
- 复发性成人 T 细胞白血病/淋巴瘤
- 复发性皮肤 T 细胞非霍奇金淋巴瘤
- 复发性蕈样肉芽肿/Sezary 综合征
- 复发性小淋巴细胞淋巴瘤
- III 期成人伯基特淋巴瘤
- III 期成人弥漫性大细胞淋巴瘤
- III 期成人弥漫性混合细胞淋巴瘤
- III 期成人弥漫性小裂细胞淋巴瘤
- III 期成人霍奇金淋巴瘤
- III 期成人 T 细胞白血病/淋巴瘤
- III 期皮肤 T 细胞非霍奇金淋巴瘤
- III 期 1 级滤泡性淋巴瘤
- III 期 2 级滤泡性淋巴瘤
- III 期 3 级滤泡性淋巴瘤
- III 期套细胞淋巴瘤
- III期边缘区淋巴瘤
- III 期蕈样肉芽肿/Sezary 综合征
- III 期小淋巴细胞淋巴瘤
- IV 期成人伯基特淋巴瘤
- IV 期成人弥漫性大细胞淋巴瘤
- IV 期成人弥漫性混合细胞淋巴瘤
- IV 期成人弥漫性小裂细胞淋巴瘤
- IV 期成人霍奇金淋巴瘤
- IV 期成人 T 细胞白血病/淋巴瘤
- IV 期皮肤 T 细胞非霍奇金淋巴瘤
- IV 期 1 级滤泡性淋巴瘤
- IV 期 2 级滤泡性淋巴瘤
- IV 期 3 级滤泡性淋巴瘤
- IV 期套细胞淋巴瘤
- IV 期边缘区淋巴瘤
- IV 期蕈样肉芽肿/Sezary 综合征
- IV 期小淋巴细胞淋巴瘤
干预/治疗
详细说明
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) in patients with metastatic or unresectable solid tumors or lymphomas.
II. Determine the safety and toxicity of this drug in these patients. III. Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
IV. Determine the recommended phase II dose of this drug for future studies.
SECONDARY OBJECTIVES:
I. Determine tumor response in patients treated with this drug.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) IV over 1-6 hours on days 1-3 or 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 1-2 patients receive accelerated escalating doses of 17-DMAG until at least 1 of 2 patients experience dose-limiting toxicity (DLT). Cohorts are then expanded to 3-6 patients who receive escalating doses (in a standard manner) of 17-DMAG 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 DLT.
Patients are followed at 4 weeks.
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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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15232
- University of Pittsburgh
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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
Inclusion Criteria:
Histologically confirmed solid tumor or lymphoma
- Metastatic or unresectable disease
- Standard curative or palliative measures do not exist or are no longer effective
- No known brain metastases
- Performance status - ECOG 0-2
- Performance status - Karnofsky 60-100%
- More than 12 weeks
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9.0 g/dL
- ALT and AST ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ normal
- Creatinine ≤ 1.25 times ULN
- Creatinine clearance ≥ 60 mL/min
- QTc < 450 msec for male patients (470 msec for female patients)
- LVEF > 40% by MUGA
- No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
- No myocardial infarction or active ischemic heart disease within the past year
- No New York Heart Association class III or IV congestive heart failure
- No poorly controlled angina
- No uncontrolled dysrhythmia requiring medication
- No left bundle branch block
- No history of congenital long QT syndrome
- No other significant cardiac disease
- Pulse oximetry at rest or on exercise > 88%
No symptomatic pulmonary disease (e.g., chronic obstructive or restrictive pulmonary disease, etc.) or any of the following are allowed:
- Pulmonary disease requiring medication
- History of dyspnea, dyspnea on exertion, or paroxysmal nocturnal dyspnea
- Patients meeting the Medicare criteria for home oxygen or are on oxygen
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double barrier contraception 1 week before, during, and for at least 2 weeks after study participation
- No uncontrolled illness
- No active or ongoing infection
- No history of allergic reaction attributed to compounds of similar chemical or biological composition to 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG)
- No psychiatric illness or social situation that would preclude study compliance
- No concurrent routine colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- Concurrent hormonal therapy allowed
- At least 4 weeks since prior radiotherapy and recovered
- No prior radiation that included the heart in the field (e.g., mantle)
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent anticancer agents or therapies
- No concurrent medication that would prolong the QTc interval
- No other concurrent investigational agents
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 |
---|---|
实验性的:Treatment (alvespimycin hydrochloride)
Patients receive 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) IV over 1-6 hours on days 1-3 or 1-5.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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相关研究
鉴于IV
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Maximum tolerated dose of alvespimycin hydrochloride
大体时间:21 days
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21 days
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Toxicity graded using the NCI CTCAE version 3.0
大体时间:Up to 4 weeks
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Up to 4 weeks
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Recommended phase II dose (RP2D) of alvespimycin hydrochloride for future studies determined by toxicity assessments
大体时间:21 days
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21 days
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Pharmacokinetics of alvespimycin hydrochloride in blood, urine, and tumor tissue
大体时间:21 days
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Analyzed by both non-compartmental and compartmental methods.
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21 days
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次要结果测量
结果测量 |
大体时间 |
---|---|
Tumor response assessed by tumor measurements
大体时间:Up to 4 weeks
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Up to 4 weeks
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合作者和调查者
调查人员
- 首席研究员:Chandra Belani、University of Pittsburgh
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
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
其他相关的 MeSH 术语
- 病理过程
- 心血管疾病
- 血管疾病
- 病毒病
- 感染
- 免疫系统疾病
- 组织学类型的肿瘤
- 肿瘤
- 淋巴增生性疾病
- 淋巴系统疾病
- 免疫增生性疾病
- 按部位分类的肿瘤
- 疾病属性
- 疾病
- 血液病
- 出血性疾病
- 止血障碍
- 副蛋白血症
- 血液蛋白失调
- DNA 病毒感染
- 细菌感染和真菌病
- 肿瘤病毒感染
- 肿瘤,浆细胞
- 白血病、淋巴细胞
- 爱泼斯坦-巴尔病毒感染
- 疱疹病毒科感染
- 白血病,B细胞
- 眼部肿瘤
- 淋巴结肿大
- 淋巴瘤
- 淋巴瘤,滤泡性
- 淋巴瘤,B细胞
- 淋巴瘤,大 B 细胞,弥漫性
- 综合症
- 白血病
- 霍奇金病
- 复发
- 淋巴瘤,非霍奇金
- 真菌病
- 伯基特淋巴瘤
- 淋巴瘤,套细胞
- 淋巴瘤、B 细胞、边缘区
- 华氏巨球蛋白血症
- 白血病、淋巴细胞性、慢性、B 细胞
- 淋巴瘤,T细胞
- 淋巴瘤,T细胞,皮肤
- 白血病,T细胞
- 白血病-淋巴瘤,成人 T 细胞
- 蕈样肉芽肿
- 塞扎里综合症
- 淋巴瘤、大细胞、间变性
- 眼内淋巴瘤
- 免疫母细胞性淋巴结肿大
其他研究编号
- NCI-2012-02620
- PCI-03-153
- U01CA069912 (美国 NIH 拨款/合同)
- U01CA099168 (美国 NIH 拨款/合同)
- U01CA062502 (美国 NIH 拨款/合同)
- CDR0000378189 (注册表标识符:PDQ (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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