Broccoli Sprout Extract in Treating Patients With Transitional Cell Bladder Cancer Undergoing Surgery
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Purpose
Rationale: Broccoli sprout extract contains ingredients that may prevent or slow the growth of certain cancers.
Purpose: This phase I trial is studying the side effects of broccoli sprout extract in treating patients with transitional cell bladder cancer undergoing surgery.
| Condition | Intervention | 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 |
Phase 1 |
| 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: | A Phase I Pre-cystectomy Trial of Broccoli Extract in Patients With Advanced Bladder Cancer |
- Toxicity as assessed by National Cancer Institute (NCI) Common Toxicity Criteria version 3.0 [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
- Apoptosis, cell proliferation, and microvessel density [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 12 |
| Study Start Date: | April 2010 |
| Estimated Primary Completion Date: | July 2013 (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 |
Inclusion Criteria:
- Any patient eligible for cystectomy
- Patients must be considered fit for surgical resection of the bladder with curative intent
- No chemotherapy, surgery (excluding transurethral resection of bladder tumor [TURBT], 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 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| Contact: AskRPCI, MD | 1-877-275-7724 | AskRPCI@Roswellpark.org |
| United States, New York | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263 | |
| 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: | March 5, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Carcinoma Carcinoma, Transitional Cell Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Neoplasms Urinary Bladder Diseases Urologic Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 23, 2013