NCT00006476已完成1 期
A Phase I Study of Intravesicular Suramin in Recurrent Superficial Bladder 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
- 15
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Suramin may stop the growth of bladder cancer by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of suramin in treating patients who have recurrent bladder cancer.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of suramin in patients with recurrent superficial bladder cancer.
- Confirm that there is no significant systemic absorption of this drug when administered intravesically in these patients.
OUTLINE: This is a dose escalation study.
At approximately 14-18 days after surgical resection of bladder tumor(s), patients receive intravesicular suramin via urethral catheter installation into the bladder over 2 hours weekly for 6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of suramin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients develop 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 proven recurrent superficial bladder cancer
- •Intermediate prognosis as defined by the following:
- •Recurrent, multiple Ta, T1 carcinoma
- •Multiple (1-7) tumors
- •Tumors resected previously must be histological grade G1 or G2 OR
- •Previously treated superficial bladder cancer requiring followup cystoscopy
- •Recurrent disease diagnosed at surgery
- •No tumor invasion into muscle or carcinoma in situ
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3,500/mm3
- •Platelet count at least 150,000/mm3
- •No clinically significant hepatic disease
- •Creatinine clearance greater than 60 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 6 months after study
- •No history of adrenal insufficiency
- •No other malignancy within the past 5 years except adequately treated cone-biopsied carcinoma in situ of the cervix or nonmelanoma skin cancer
- •No history of difficult catheterization
- •No confusion or disorientation
- •No other condition that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent biologic therapy
- •Chemotherapy:
- •No concurrent chemotherapy
- •Endocrine therapy:
- •No concurrent corticosteroids
- •Radiotherapy:
- •No prior radiotherapy to the bladder
- •No concurrent radiotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior major thoracic or abdominal surgery
- •Recovered from prior therapy and stable for 4 weeks
- •At least 6 weeks since prior intravesicular therapy
- •No prior or concurrent investigational drugs
- •No concurrent anticoagulants
排除标准
- 未提供
研究者
研究点 (1)
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