NCT00042900已完成1 期
A Phase I Clinical And Pharmacological Study Of Pyroxamide (NSC 696085) In Patients With Advanced Malignancies
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 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 pyroxamide in treating patients who have advanced cancer.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of pyroxamide in patients with advanced malignancies.
- Define, qualitatively and quantitatively, the dose-limiting and non-dose-limiting toxic effects of this drug in these patients.
- Describe the pharmacologic behavior of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive pyroxamide IV continuously over 5-7 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of pyroxamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience 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 or cytologically confirmed solid tumor or hematologic malignancy
- •Disease that has failed standard therapies (e.g., surgery, radiotherapy, endocrine therapy, or chemotherapy) or for which no curative or life- prolonging therapy is available
- •Measurable or clinically evaluable disease
- •Elevated tumor marker is acceptable for evaluable disease
- •No known carcinomatous meningitis, primary brain tumors, or metastatic brain disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 125,000/mm^3
- •Hemoglobin at least 9.0 g/dL
- •Bilirubin normal
- •AST no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
- •PT no greater than 1.5 times ULN
- •Creatinine normal
- •HIV-positive status allowed
- •Prior malignancy allowed
- •No severe physical or emotional illness that would preclude study participation
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent bone marrow growth factors
- •Chemotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas or mitomycin)
- •Endocrine therapy
- •See Disease Characteristics
- •Radiotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior wide-field radiotherapy and recovered
- •At least 2 weeks since prior limited-field radiotherapy and recovered
- •Recovered from prior radiotherapy
- •See Disease Characteristics
- •No other concurrent antitumor treatment
排除标准
- 未提供
研究者
研究点 (2)
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