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

• Sponsor: Roswell Park Cancer Institute (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01108003
• Collaborator: Johns Hopkins University (Other), National Cancer Institute (NCI) (NIH)
• Enrollment: 7
• Location: 1
• Arms: 2
• Duration (Months): 66
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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; Other: Mango Juice	N/A

Detailed Description

Primary Objectives:

1. 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:

1. Establish the safety of administration of the broccoli extract on the bladder surgery specifically.

2. Determine the levels of isothiocyanates and their metabolites in urine, blood, benign urothelium and bladder cancer tissue.

3. Assess the antitumor effects of broccoli extract on the primary bladder tumor by measuring angiogenesis, cell proliferation and apoptosis.

4. 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 Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Pre-cystectomy Trial of Broccoli Extract in Patients With Superficial or Locally Advanced Bladder Cancer
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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
Placebo Comparator: Arm 2 Patients receive mango juice alone.	Other: Mango Juice; given orally

Outcome Measures

Primary Outcome Measures

1. Toxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0 [14 days]

   Number of participants with an adverse event.

Secondary Outcome Measures

1. Apoptosis, Cell Proliferation, and Microvessel Density [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Roswell Park Cancer Institute	Buffalo	New York	United States	14263

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Roswell Park Cancer Institute
• ClinicalTrials.gov Identifier: NCT01108003
• Other Study ID Numbers: I 129408; NCI-2010-00759
• First Posted: Apr 21, 2010
• Last Update Posted: Jun 26, 2017
• Last Verified: May 1, 2017

• Additional relevant MeSH terms: Urinary Bladder Neoplasms; Carcinoma, Transitional Cell

Study Results

Participant Flow

Arm/Group Title	Arm I	Arm 2
Arm/Group Description	Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity. broccoli sprout extract: Given orally laboratory biomarker analysis: Correlative studies	Patients receive mango juice alone. Mango Juice: given orally
Period Title: Overall Study
STARTED	4	3
COMPLETED	4	3
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Arm I	Arm 2	Total
Arm/Group Description	Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity. broccoli sprout extract: Given orally laboratory biomarker analysis: Correlative studies	Patients receive mango juice alone. Mango Juice: given orally	Total of all reporting groups
Overall Participants	4	3	7
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	4 100%	3 100%	7 100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	74 (5.3)	73 (4.9)	74 (4.7)
Sex: Female, Male (Count of Participants)
Female	1 25%	0 0%	1 14.3%
Male	3 75%	3 100%	6 85.7%

Outcome Measures

1. Primary Outcome

Title	Toxicity as Assessed by National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0
Description	Number of participants with an adverse event.
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

All treated and eligible patients.

Arm/Group Title	Arm I	Arm 2
Arm/Group Description	Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity. broccoli sprout extract: Given orally laboratory biomarker analysis: Correlative studies	Patients receive mango juice alone. Mango Juice: given orally
Measure Participants	4	3
Number [participants]	4 100%	3 100%

2. Secondary Outcome

Title	Apoptosis, Cell Proliferation, and Microvessel Density
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Arm I	Arm 2
Arm/Group Description	Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity. broccoli sprout extract: Given orally laboratory biomarker analysis: Correlative studies	Patients receive mango juice alone. Mango Juice: given orally
Measure Participants	0	0

Adverse Events

Arm/Group Title	Arm I		Arm 2
Arm/Group Description	Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity. broccoli sprout extract: Given orally laboratory biomarker analysis: Correlative studies		Patients receive mango juice alone. Mango Juice: given orally
All Cause Mortality
	Arm I		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm I		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/4 (50%)		1/3 (33.3%)
Infections and infestations
Fungaemia	1/4 (25%)	1	0/3 (0%)	0
Sepsis	0/4 (0%)	0	1/3 (33.3%)	1
Urosepsis	1/4 (25%)	1	0/3 (0%)	0
Other (Not Including Serious) Adverse Events
	Arm I		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/4 (100%)		3/3 (100%)
Blood and lymphatic system disorders
Anaemia	2/4 (50%)	3	2/3 (66.7%)	2
Lymphopenia	1/4 (25%)	1	0/3 (0%)	0
Gastrointestinal disorders
Constipation	2/4 (50%)	2	2/3 (66.7%)	2
Ileus	1/4 (25%)	1	0/3 (0%)	0
Nausea	2/4 (50%)	2	0/3 (0%)	0
General disorders
Pain	3/4 (75%)	3	0/3 (0%)	0
Pyrexia	1/4 (25%)	1	0/3 (0%)	0
Infections and infestations
Skin infection	0/4 (0%)	0	1/3 (33.3%)	1
Investigations
Aspartate aminotransferase increased	0/4 (0%)	0	1/3 (33.3%)	1
Blood albumin decreased	1/4 (25%)	1	1/3 (33.3%)	1
Blood alkaline phosphatase increased	1/4 (25%)	1	0/3 (0%)	0
Blood calcium decreased	1/4 (25%)	1	0/3 (0%)	0
Blood creatinine increased	1/4 (25%)	2	1/3 (33.3%)	1
Blood magnesium increased	0/4 (0%)	0	1/3 (33.3%)	1
Cardiac enzymes increased	1/4 (25%)	1	0/3 (0%)	0
Electrocardiogram abnormal	1/4 (25%)	1	0/3 (0%)	0
Haemoglobin decreased	1/4 (25%)	2	1/3 (33.3%)	1
Lymphocyte count decreased	2/4 (50%)	8	3/3 (100%)	3
Platelet count decreased	1/4 (25%)	2	0/3 (0%)	0
White blood cell analysis increased	0/4 (0%)	0	1/3 (33.3%)	1
Metabolism and nutrition disorders
Hyperglycaemia	3/4 (75%)	3	3/3 (100%)	3
Hypermagnesaemia	1/4 (25%)	1	0/3 (0%)	0
Hyperphosphataemia	0/4 (0%)	0	1/3 (33.3%)	1
Hypocalcaemia	1/4 (25%)	1	3/3 (100%)	3
Hypokalaemia	1/4 (25%)	1	1/3 (33.3%)	1
Hypomagnesaemia	1/4 (25%)	1	0/3 (0%)	0
Hyponatraemia	1/4 (25%)	1	3/3 (100%)	3
Hypophosphataemia	1/4 (25%)	1	0/3 (0%)	0
Psychiatric disorders
Confusional state	0/4 (0%)	0	1/3 (33.3%)	1
Renal and urinary disorders
Haematuria	1/4 (25%)	1	0/3 (0%)	0
Reproductive system and breast disorders
Penile discharge	0/4 (0%)	0	1/3 (33.3%)	1
Skin and subcutaneous tissue disorders
Pruritus	1/4 (25%)	1	0/3 (0%)	0

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.