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

NCT01108003 | Terminated Results DMC

• 2 other identifiers: I 129408NCI-2010-00759
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Toxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0

  Number of participants with an adverse event.

  14 days

Secondary Outcomes (1)

• Apoptosis, Cell Proliferation, and Microvessel Density

  1 year

Study Arms (2)

Arm I

EXPERIMENTAL

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; Other: laboratory biomarker analysis

Arm 2

PLACEBO COMPARATOR

Patients receive mango juice alone.

Other: Mango Juice

Interventions

broccoli sprout extract DRUG

Given orally

Arm I

laboratory biomarker analysis OTHER

Correlative studies

Arm I

Mango Juice OTHER

given orally

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• Johns Hopkins University: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Due to the study's early termination and low accrual, data were not collected for all study objectives assessment.

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• James Marshall, PhD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2010
• First Posted: April 21, 2010
• Study Start: April 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2015
• Last Updated: June 26, 2017
• Results First Posted: June 23, 2016

Record last verified: 2017-05

Locations

US (1)