SJG-136 in Treating Patients With Advanced Solid Tumors
A Phase I Study With SJG-136 (NSC #694501) in Patients With an Advanced Solid Tumor
研究概览
详细说明
PRIMARY OBJECTIVES:
I. To determine the toxicities, pharmacokinetic profile and the recommended phase 2 dose of SJG-136 in patients with an advanced solid tumor.
SECONDARY OBJECTIVES:
I. To determine preliminary efficacy data and evaluation of correlative markers of DNA damage and apoptosis in peripheral blood lymphocytes.
OUTLINE: This is an open-label, dose-escalation study.
Patients receive SJG-136 intravenously (IV) over 20 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SJG-136 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 toxicity. At least 6 patients are treated at the MTD.
研究类型
注册 (预期的)
阶段
- 阶段1
联系人和位置
学习地点
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-
New York
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New York、New York、美国、10065
- Memorial Sloan-Kettering Cancer 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
Inclusion Criteria:
Histologically confirmed solid tumor
- Advanced disease, defined as metastatic or unresectable disease
- Measurable indicator lesions
- Standard curative or palliative measures do not exist or are no longer effective
- Previously treated CNS metastases allowed provided patient has completed local therapy AND corticosteroids have been discontinued for at least 4 weeks
- No known leptomeningeal metastases
- Performance status - ECOG 0-2
- Performance status - Karnofsky 60-100%
- More than 3 months
- WBC ≥ 3,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin ≤ 1.0 mg/dL
- AST and ALT ≤ 2.5 times upper limit of normal
- Creatinine < 1.4 mg/dL
- No congestive heart failure
- No recent myocardial infarction
- No unstable angina
- No uncontrolled hypertension
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infection
- No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drug
- No other significant medical history, unstable medical condition, or unstable systemic disease that would preclude study participation
- At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas and 8 weeks for UCN-01)
- At least 4 weeks since prior radiotherapy
- No prior radiotherapy to ≥ 25% of hematopoietic bone marrow
- Recovered from all prior therapy
- At least 4 weeks since prior investigational anticancer drugs
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
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 (SJG-136)
Patients receive SJG-136 IV over 20 minutes on days 1, 8, and 15.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
鉴于IV
|
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 |
|---|---|---|
|
Recommended phase 2 dose of SJG-136
大体时间:Day 28
|
Defined as when ≤1 out of 6 patients achieve dose-limiting toxicity (DLT) at highest dose level below the maximally administered dose.
|
Day 28
|
合作者和调查者
调查人员
- 首席研究员:Naiyer Rizvi、Memorial Sloan Kettering Cancer Center
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
其他研究编号
- NCI-2012-01462 (注册表标识符:CTRP (Clinical Trial Reporting Program))
- U01CA069856 (美国 NIH 拨款/合同)
- MSKCC-04076
- CDR0000409581
- NCI-6818
- 04-076 (Memorial Sloan-Kettering Cancer Center)
- 6818 (CTEP)
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