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

Roswell Park Comprehensive Cancer Center

Status: Terminated

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

Treatments: Other: Mango Juice; Other: laboratory biomarker analysis; Drug: broccoli sprout extract

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01108003

NCI-2010-00759

I 129408

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 2 patient groups, including a placebo group

Arm I

Experimental group

Description:

Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.

Treatment:

Other: laboratory biomarker analysis

Drug: broccoli sprout extract

Arm 2

Placebo Comparator group

Description:

Patients receive mango juice alone.

Treatment:

Other: Mango Juice