Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Pre-cystectomy Trial of Broccoli Extract in Patients With Superficial or Locally Advanced Bladder Cancer

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Toxicity as assessed by National Cancer Institute (NCI) Common Toxicity Criteria version 3.0 [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Apoptosis, cell proliferation, and microvessel density [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: April 2010
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01108003

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
Johns Hopkins University
Investigators
Principal Investigator: Roberto Pili Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01108003     History of Changes
Other Study ID Numbers: I 129408, NCI-2010-00759
Study First Received: April 19, 2010
Last Updated: September 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Transitional Cell
Urinary Bladder Neoplasms
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014