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

NCT ID: NCT01108003

Last Updated: 2017-06-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2015-10-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

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

Group Type: EXPERIMENTAL

broccoli sprout extract

Intervention Type: DRUG

Given orally

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Arm 2

Patients receive mango juice alone.

Group Type: PLACEBO_COMPARATOR

Mango Juice

Intervention Type: OTHER

given orally

Interventions

broccoli sprout extract

Given orally

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Mango Juice

given orally

Intervention Type: OTHER

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Marshall, PhD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

NCI-2010-00759

Identifier Type: -

Identifier Source: secondary_id

I 129408

Identifier Type: -

Identifier Source: org_study_id