Broccoli Sprout Extract in Treating Patients With Transitional Cell Bladder Cancer Undergoing Surgery
Stopped early · Not applicable
Conditions studied: Recurrent Bladder Cancer, Stage 0 Bladder Cancer, Stage I Bladder Cancer, Stage II Bladder Cancer, Transitional Cell Carcinoma of the Bladder
In brief
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.
Key facts
- Study ID
- NCT01108003
- Run by
- Roswell Park Cancer Institute
- People needed
- 7
- Starts
- 2010-04-01
- Expected to finish
- 2015-10-01
- Last updated by the study team
- 2017-06-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Roswell Park Cancer Institute — Buffalo, New York, United States
Full record on ClinicalTrials.gov
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