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

Not Applicable

Terminated

Conditions: Stage I Bladder Cancer
Stage 0 Bladder Cancer
Recurrent Bladder Cancer
Transitional Cell Carcinoma of the Bladder
Stage II Bladder Cancer

Interventions: Drug: broccoli sprout extract
Other: Mango Juice
Other: laboratory biomarker analysis

Registration Number: NCT01108003

Lead Sponsor: Roswell Park Cancer Institute

Brief 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.

Detailed Description: 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.

III. Assess the antitumor effects of broccoli extract on the primary bladder tumor by measuring angiogenesis, cell proliferation and apoptosis.

IV. Determine the feasibility of treating patients with 200 micro mol isothiocyanate per dose per day of broccoli sprout extract in future therapeutic and prevention clinical trials.

Outline: Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 4 weeks.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 7

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I	broccoli sprout extract	Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.
Arm I	laboratory biomarker analysis	Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.
Arm 2	Mango Juice	Patients receive mango juice alone.

Primary Outcome Measures