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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Recurrent Bladder Cancer Stage 0 Bladder Cancer Stage I Bladder Cancer Stage II Bladder Cancer Transitional Cell Carcinoma of the Bladder Drug: broccoli sprout extract Other: laboratory biomarker analysis Other: Mango Juice Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Pre-cystectomy Trial of Broccoli Extract in Patients With Superficial or Locally Advanced Bladder Cancer
Study Start Date : April 2010
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arms and Interventions
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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.
 Drug: broccoli sprout extract
Given orally

Other: laboratory biomarker analysis
Correlative studies
Placebo Comparator: Arm 2
Patients receive mango juice alone.
 Other: Mango Juice
given orally


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Apoptosis, Cell Proliferation, and Microvessel Density [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108003


Locations
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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
Johns Hopkins University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: James Marshall, PhD Roswell Park Cancer Institute
More Information
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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01108003    
Other Study ID Numbers: I 129408
NCI-2010-00759
First Posted: April 21, 2010    Key Record Dates
Results First Posted: June 23, 2016
Last Update Posted: June 26, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Urinary Bladder Diseases
Urologic Diseases
Male Urogenital Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type