Trial record 1 of 1 for:    NCT01108003
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Broccoli Sprout Extract in Treating Patients With Transitional Cell Bladder Cancer Undergoing Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01108003
First received: April 19, 2010
Last updated: September 19, 2014
Last verified: September 2014

April 19, 2010
September 19, 2014
April 2010
September 2014   (final data collection date for primary outcome measure)
Toxicity as assessed by National Cancer Institute (NCI) Common Toxicity Criteria version 3.0 [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Toxicity as assessed by NCI Common Toxicity Criteria version 3.0 [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01108003 on ClinicalTrials.gov Archive Site
Apoptosis, cell proliferation, and microvessel density [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Apoptosis, cell proliferation, and microvessel density [ Time Frame: Pre- and post-treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
    Given orally
  • Other: laboratory biomarker analysis
    Correlative studies
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
7
Not Provided
September 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01108003
I 129408, NCI-2010-00759
Yes
Roswell Park Cancer Institute
Roswell Park Cancer Institute
Johns Hopkins University
Principal Investigator: Roberto Pili Roswell Park Cancer Institute
Roswell Park Cancer Institute
September 2014

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