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

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ClinicalTrials.gov Identifier: NCT01108003
Recruitment Status : Terminated (low accrual)
First Posted : April 21, 2010
Results First Posted : June 23, 2016
Last Update Posted : June 26, 2017
Sponsor:
Collaborators:
Johns Hopkins University
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Tracking Information
First Submitted Date  ICMJE April 19, 2010
First Posted Date  ICMJE April 21, 2010
Results First Submitted Date  ICMJE May 16, 2016
Results First Posted Date  ICMJE June 23, 2016
Last Update Posted Date June 26, 2017
Study Start Date  ICMJE April 2010
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2016)
Toxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0 [ Time Frame: 14 days ]
Number of participants with an adverse event.
Original Primary Outcome Measures  ICMJE
 (submitted: April 20, 2010)
Toxicity as assessed by NCI Common Toxicity Criteria version 3.0 [ Time Frame: 14 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2010)
Apoptosis, Cell Proliferation, and Microvessel Density [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2010)
Apoptosis, Cell Proliferation, and Microvessel Density [ Time Frame: Pre- and post-treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Broccoli Sprout Extract in Treating Patients With Transitional Cell Bladder Cancer Undergoing Surgery
Official Title  ICMJE Pilot Pre-cystectomy Trial of Broccoli Extract in Patients With Superficial or Locally Advanced Bladder Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Recurrent Bladder Cancer
  • Stage 0 Bladder Cancer
  • Stage I Bladder Cancer
  • Stage II Bladder Cancer
  • Transitional Cell Carcinoma of the Bladder
Intervention  ICMJE
  • Drug: broccoli sprout extract
    Given orally
  • Other: laboratory biomarker analysis
    Correlative studies
  • Other: Mango Juice
    given orally
Study Arms  ICMJE
  • Experimental: Arm I
    Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Drug: broccoli sprout extract
    • Other: laboratory biomarker analysis
  • Placebo Comparator: Arm 2
    Patients receive mango juice alone.
    Intervention: Other: Mango Juice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 19, 2014)
7
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2010)
12
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01108003
Other Study ID Numbers  ICMJE I 129408
NCI-2010-00759
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roswell Park Cancer Institute
Study Sponsor  ICMJE Roswell Park Cancer Institute
Collaborators  ICMJE
  • Johns Hopkins University
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: James Marshall, PhD Roswell Park Cancer Institute
PRS Account Roswell Park Cancer Institute
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP