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

Pilot Pre-cystectomy Trial of Broccoli Extract in Patients With Superficial or Locally Advanced Bladder Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Recurrent Bladder Cancer; Transitional Cell Carcinoma of the Bladder; Stage 0 Bladder Cancer; Stage I Bladder Cancer; Stage II Bladder Cancer
• Intervention / Treatment: Other: laboratory biomarker analysis; Drug: broccoli sprout extract; Other: Mango Juice

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I; Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.	Other: laboratory biomarker analysis; Correlative studies; Drug: broccoli sprout extract; Given orally
Placebo Comparator: Arm 2; Patients receive mango juice alone.	Other: Mango Juice; given orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0	Number of participants with an adverse event.	14 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Apoptosis, Cell Proliferation, and Microvessel Density	1 year

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Collaborators: Johns Hopkins University; National Cancer Institute (NCI)
• Investigators: Principal Investigator: James Marshall, PhD, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: April 19, 2010
• First Submitted That Met QC Criteria: April 20, 2010
• First Posted (Estimate): April 21, 2010

Study Record Updates

• Last Update Posted (Actual): June 26, 2017
• Last Update Submitted That Met QC Criteria: May 31, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell
• Other Study ID Numbers: I 129408; NCI-2010-00759