A Phase I Pre-cystectomy Trial of Broccoli Extract in Patients With Advanced Bladder Cancer

Inclusion Criteria:

- Any patient eligible for cystectomy

- Patients must be considered fit for surgical resection of the bladder with curative
intent

- No chemotherapy, surgery (excluding transurethral resection of bladder tumor [TURBT],
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

Exclusion Criteria:

- 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 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)