NCT00075660已完成2 期
A Phase II Study of Triapine (NSC 663249) in Previously Untreated Patients With Recurrent Renal Cell Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 8
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as 3-AP, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of 3-AP in treating patients who have locally recurrent or metastatic renal cell (kidney) carcinoma (cancer).
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of 3-AP (Triapine®), in terms of objective response rate, in patients with previously untreated locally recurrent or metastatic renal cell carcinoma.
Secondary
- Determine the adverse events and tolerability of this drug in these patients.
- Determine the time to disease progression and overall survival of patients treated with this drug.
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 confirmed renal cell carcinoma
- •Locally recurrent OR metastatic disease
- •Incurable by standard therapy
- •Clinically and/or radiologically measurable disease
- •At least 1 unidimensionally measurable lesion* at least 20 mm by x-ray, physical exam, or non-spiral CT scan OR at least 10 mm by spiral CT scan
- •If the sole site of measurable disease is in a previously irradiated field, there must be documented disease progression at that site NOTE: *Bone lesions are not considered measurable disease
- •No documented brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •No glucose-6-phosphate dehydrogenase (G6PD) deficiency* NOTE: *Screening for G6PD deficiency is required for patients of African, Asian, or Mediterranean descent
- •Bilirubin normal
- •AST or ALT no greater than 2.5 times upper limit of normal (ULN)
- •Creatinine no greater than 1.5 times ULN
- •Creatinine clearance at least 50 mL/min
- •Cardiovascular
- •No myocardial infarction within the past 6 months
- •No symptomatic congestive heart failure
- •No unstable angina
- •No active cardiomyopathy
- •No cardiac arrhythmia
- •No uncontrolled hypertension
- •No pulmonary disease requiring oxygen
- •Immunologic
- •HIV negative
- •No known hypersensitivity to compounds of similar chemical or biological composition to 3-AP (Triapine®)
- •No active uncontrolled or serious infection
- •No immunodeficiency
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other prior malignancy except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumor with no evidence of disease for at least 5 years
- •No history of significant neurologic or psychiatric disorder (e.g., uncontrolled psychotic disorders) that would preclude giving informed consent or complying with study requirements
- •No active peptic ulcer disease
- •No other serious illness or medical condition that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 3 months since prior interferon for advanced or recurrent disease
- •No other prior immunotherapy for advanced or recurrent disease
- •No prior gene therapy
- •Chemotherapy
- •No prior systemic chemotherapy for advanced or recurrent disease
- •Endocrine therapy
- •Not specified
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排除标准
- 未提供
研究者
研究点 (8)
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