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

Transitional Cell Carcinoma of the Bladder Clinical Trial

Official title:

Pilot Pre-cystectomy Trial of Broccoli Extract in Patients With Superficial or Locally Advanced Bladder Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01108003
• Other study ID #: I 129408
• Secondary ID: NCI-2010-00759
• Status: Terminated
• Phase: N/A
• First received: April 19, 2010
• Last updated: November 19, 2015
• Start date: April 2010
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: October 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• broccoli sprout extract
Given orally

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (3)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	Johns Hopkins University, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity as assessed by National Cancer Institute (NCI) Common Toxicity Criteria version 3.0		14 days	Yes
Secondary	Apoptosis, cell proliferation, and microvessel density		1 year	No