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

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

Tracking Information

• First Submitted Date: April 19, 2010
• First Posted Date: April 21, 2010
• Results First Submitted Date: May 16, 2016
• Results First Posted Date: June 23, 2016
• Last Update Posted Date: June 26, 2017
• Study Start Date: April 2010
• Actual Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: April 20, 2010): Toxicity as assessed by NCI Common Toxicity Criteria version 3.0 [ Time Frame: 14 days ]
• Current Secondary Outcome Measures (submitted: May 16, 2016): Apoptosis, Cell Proliferation, and Microvessel Density [ Time Frame: 1 year ]
• Original Secondary Outcome Measures (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: Broccoli Sprout Extract in Treating Patients With Transitional Cell Bladder Cancer Undergoing Surgery
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

• Drug: broccoli sprout extract
  Given orally
• Other: laboratory biomarker analysis
  Correlative studies
• Other: Mango Juice
  given orally

Study Arms

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: September 19, 2014): 7
• Original Estimated Enrollment (submitted: April 20, 2010): 12
• Actual Study Completion Date: October 2015
• Actual Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01108003
• Other Study ID Numbers: I 129408; NCI-2010-00759
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Roswell Park Cancer Institute
• Original Responsible Party: Pili, Roberto, Roswell Park Cancer Institute
• Current Study Sponsor: Roswell Park Cancer Institute
• Original Study Sponsor: Same as current

Collaborators

• Johns Hopkins University
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: James Marshall, PhD; Roswell Park Cancer Institute

• PRS Account: Roswell Park Cancer Institute
• Verification Date: May 2017