Pilot Pre-cystectomy Trial of Broccoli Extract in Patients With Superficial or Locally Advanced Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Toxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0
研究概览
简要总结
Rationale: Broccoli sprout extract contains ingredients that may prevent or slow the growth of certain cancers.
Purpose: This pilot study is studying the side effects of broccoli sprout extract in treating patients with transitional cell bladder cancer undergoing surgery.
详细描述
Primary Objectives:
I. To determine the tolerability and toxicity of a broccoli sprout extract (providing 200 micro mol isothiocyanate/dose/per day) given for 14 days in patients destined to undergo definitive bladder resection for bladder cancer.
Secondary Objectives:
I. Establish the safety of administration of the broccoli extract on the bladder surgery specifically.
II. Determine the levels of isothiocyanates and their metabolites in urine, blood, benign urothelium and bladder cancer tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient eligible for superficial bladder cancer
- •Patients must be considered fit for surgical resection with curative intent
- •No chemotherapy, surgery (excluding transurethral resection of bladder tumor [TURBT], BCG or radiotherapy in the prior 4 weeks [6 weeks for mitomycin C or interferon])
- •No previous treatment/ingestion with broccoli extracts
- •Eastern Oncology Group (ECOG) performance status 0-2
- •AST and ALT =< 2.5 times ULN (upper limit of normal)
- •Total bilirubin =< 2.0 mg/dL
- •Creatinine Clearance >= 30 ml/min
- •WBC > 3000 mm^3
- •Absolute neutrophil count > 1000/mm^3
- •Platelets > 100,000/mm^3
- •All patients must sign a study-specific consent form indicating that they are aware of the investigational nature of this study
排除标准
- •Have participated in any clinical trial involving conventional or investigational drugs or devices within the previous 4 weeks
- •Prior radiation to the pelvis
- •Intractable urinary tract infection that has not responded to antibiotic treatment
- •Active, uncontrolled bacterial, viral, or fungal infection including HIV
- •Have had major surgery within 4 weeks of starting therapy (not including placement of vascular access device or TURBT)
- •Poor medical risk in the opinion of the treating oncologist due to non-malignant systemic disease
- •Pregnant or lactating patients: patients must be postmenopausal or practicing an accepted form of birth control; for patients where pregnancy is a possibility, a pregnancy test will be required prior to initiation of therapy
- •Have a history of myocardial infarction or angina pectoris/angina equivalent in the last 6 months (the patient may be on anti-anginal medications if the symptoms have been entirely controlled for greater than 6 months), or have uncontrolled congestive heart failure
- •Have a history of bleeding disorders or thrombosis; patients on therapeutic doses of anticoagulation (including coumadin or heparins) are not permitted on trial (this exclusion criterion does not include those patients receiving low dose or prophylactic dose anticoagulation [i.e. coumadin 1 mg daily in patients with central intravenous lines])
- •Radiotherapy during the course of the trial
- •Inability to tolerate proposed treatment or procedures
- •Have additional uncontrolled serious medical conditions or psychiatric illness
- •Patients with a history of hepatitis (including but not exclusive to viral hepatitis auto-immune or alcoholic)
- •Patients with active thyroid disease (patients with hypothyroidism, adequately replaced on a stable dose of thyroid replacement will be allowed on trial)
研究组 & 干预措施
Arm I
Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.
干预措施: broccoli sprout extract (Drug)
Arm I
Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
Arm 2
Patients receive mango juice alone.
干预措施: Mango Juice (Other)
结局指标
主要结局
Toxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0
时间窗: 14 days
Number of participants with an adverse event.
次要结局
- Apoptosis, Cell Proliferation, and Microvessel Density(1 year)