NCT00049699已完成1 期
A Phase I Trial of VNP40101M, a Novel Alkylating Agent, Administered Weekly for Patients With Advanced or Metastatic Cancer
Vion Pharmaceuticals6 个研究点 分布在 1 个国家开始时间: 2002年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 6
研究概览
简要总结
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 VNP40101M in treating patients who have advanced or metastatic cancer.
详细描述
OBJECTIVES:
- Determine the toxic effects of VNP40101M in patients with advanced or metastatic solid tumor or lymphoma.
- Determine the maximum tolerated dose of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the antitumor effects of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive VNP40101M IV over 15 minutes on days 1, 8, and 15. Treatment repeats every 28 days.
Cohorts of 3-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose is determined.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed advanced or metastatic solid tumor or lymphoma for which no curative or standard effective therapy exists
- •Measurable or evaluable disease
- •Primary brain tumors or brain metastases allowed provided neurologic deficits are stable and do not preclude study compliance
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hematocrit at least 30% (transfusion allowed)
- •No bleeding diathesis
- •PT and PTT no greater than 1.5 times the upper limit of normal (ULN)
- •Bilirubin no greater than 1.5 times ULN
- •ALT and AST no greater than 1.5 times ULN (3 times ULN if liver metastases present)
- •Albumin at least 2.5 gm/dL
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular
- •At least 3 months since prior myocardial infarction
- •No symptomatic coronary artery disease
- •No arrhythmias requiring medication
- •No uncontrolled congestive heart failure
- •No dyspnea on minimal or moderate exertion
- •DLCO and FEV1 at least 60% predicted
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No uncontrolled active bleeding (e.g., active peptic ulcer disease)
- •No active infection
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Recovered from acute toxicities of prior biologic therapy (persisting, chronic toxicity allowed if stable and no greater than grade 1)
- •Chemotherapy
- •More than 6 months since prior high-dose chemotherapy with stem cell support
- •More than 3 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin or nitrosoureas)
- •Recovered from acute toxicities of prior chemotherapy (persisting, chronic toxicity allowed if stable and no greater than grade 1)
- •Endocrine therapy
- •At least 2 weeks since prior hormonal therapy
- •Radiotherapy
- •Recovered from acute toxicities of prior radiotherapy (persisting, chronic toxicity allowed if stable and no greater than grade 1)
- •At least 2 weeks since prior surgery
- •No other concurrent standard or investigational treatment for cancer
- •No concurrent disulfiram
排除标准
- 未提供
研究者
研究点 (6)
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