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
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.
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) |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Roswell Park Cancer Institute | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
Roswell Park Cancer Institute | Johns Hopkins University, National Cancer Institute (NCI) |
United States,
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 |
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