NCT00025129已完成1 期
A Phase I Trial of VNP4010M, A Novel Alkylating Agent for Patients With Advanced or Metastatic Cancer
Vion Pharmaceuticals6 个研究点 分布在 1 个国家开始时间: 2001年3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 solid tumors or lymphomas.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of VNP40101M in patients with advanced solid tumors or lymphomas.
- Determine the toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the anti-tumor effects of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive VNP40101M IV over 15 minutes on day 1. Treatment repeats every 4 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose (MTD) is determined. The MTD is defined as the highest dose at which no more than 1 of 6 patients experiences dose-limiting toxicity.
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 and/or metastatic solid tumor or lymphoma for which no curative or standard effective therapy exists
- •Measurable or evaluable metastatic disease
- •No other hematologic malignancy
- •No large pleural, pericardial, or peritoneal effusions
- •No requirement for immediate palliative treatment, including surgery
- •No symptomatic brain metastases or metastases with substantial edema
- •Asymptomatic brain metastases or primary CNS disease allowed if neurologic deficits are stable
- •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 active uncontrolled bleeding
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •ALT and AST no greater than 1.5 times ULN (3 times ULN if liver metastases present)
- •Alkaline phosphatase no greater than 1.5 times ULN (3 times ULN if liver or bone metastases present)
- •PT and aPTT no greater than 1.5 times ULN
- •Albumin at least 2.5 g/dL
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •Ejection fraction at least 45%
- •No active heart disease
- •No myocardial infarction within the past 3 months
- •No symptomatic coronary artery disease
- •No arrhythmias requiring medication
- •No uncontrolled congestive heart failure
- •DLCO and FEV_1 at least 60% of predicted
- •No dyspnea with minimal to moderate exertion
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study participation
- •HIV negative
- •No active infection
- •Persistent stable chronic toxic effects from prior therapy allowed if no greater than grade 1
- •No bleeding diathesis (e.g., active peptic ulcer disease)
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 3 weeks since prior biologic agents and recovered
- •At least 6 months since prior high-dose chemotherapy regimen with stem cell support
- •Chemotherapy:
- •See Biologic therapy
- •At least 3 weeks since prior cytotoxic agents (6 weeks for nitrosoureas or mitomycin) and recovered
- •Endocrine therapy:
- •At least 2 weeks since prior hormonal therapy and recovered
- •Radiotherapy:
- 另有 6 项未显示
排除标准
- 未提供
研究者
研究点 (6)
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