NCT00003890已完成1 期
A Phase I Study of MG98 Given as a 2 Hour Twice Weekly IV Infusion in Patients With Advanced Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of MG98 in treating patients who have advanced solid tumors.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of MG98 in patients with advanced solid tumors.
- Assess the safety, toxicity, and pharmacokinetics of this treatment regimen in this patient population.
- Evaluate the effectiveness of this treatment regimen in these patients.
OUTLINE: This is a dose escalation, multicenter study.
Patients receive MG98 IV over 2 hours twice weekly for 3 weeks. Courses are repeated every 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
The dose of MG98 is escalated in cohorts of 1-6 patients 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.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically proven advanced solid tumor unresponsive to existing therapy or for which no curative therapy exists
- •Evidence of disease in addition to tumor marker elevation
- •CNS metastases allowed, if adequately treated and symptoms controlled for greater than 4 months
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •Absolute granulocyte count at least 1,500/mm3
- •Platelet count at least 100,000/mm3
- •PTT normal
- •Bilirubin no greater than 1.25 times upper limit of normal (ULN)
- •SGOT or SGPT no greater than 3 times ULN (4 times ULN for liver metastases)
- •Creatinine no greater than 1.25 times ULN
- •Proteinuria less than 2+ (no greater than 500 mg in a 24 hour urinalysis)
- •No active infection
- •No other serious systemic disease
- •No known hypersensitivity to oligodeoxynucleotides
- •Adequate venous access
- •No known condition (e.g., psychological, geographical) that would prevent compliance
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after the study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent colony stimulating factors unless evidence of neutropenic infection
- •Chemotherapy:
- •No more than 3 prior chemotherapy regimens
- •At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered
- •At least 1 year since prior high dose chemotherapy with bone marrow or stem cell support
- •No concurrent chemotherapy
- •Endocrine therapy:
- •Prior hormonal therapy allowed
- •No concurrent hormonal therapy
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy and recovered
- •Concurrent palliative radiotherapy allowed
- •At least 2 weeks since prior major surgery
- •At least 3 weeks since prior investigational drug therapy
- •No other concurrent investigational drug or anticancer therapy
- •No concurrent coumadin or heparin therapy
排除标准
- 未提供
研究者
研究点 (2)
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