Broccoli Sprout Extract in Treating Patients With Transitional Cell Bladder Cancer Undergoing Surgery

• Status: Terminated
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Collaborators: Johns Hopkins University; National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• 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

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 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)