A Phase I Study With SJG-136 (NSC #694501) in Patients With an Advanced Solid Tumor
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Recommended phase 2 dose of SJG-136
研究概览
简要总结
This phase I trial is studying the side effects and best dose of SJG-136 in treating patients with advanced solid tumors. Drugs used in chemotherapy, such as SJG-136, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: SJG-136 (Drug)
结局指标
主要结局
Recommended phase 2 dose of SJG-136
时间窗: Day 28
Defined as when ≤1 out of 6 patients achieve dose-limiting toxicity (DLT) at highest dose level below the maximally administered dose.
次要结局
未报告次要终点