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

2014-08-27 03:14:27 | BioPortfolio

Summary

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.

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.

Study Design

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

Conditions

Recurrent Bladder Cancer

Intervention

broccoli sprout extract, laboratory biomarker analysis

Location

Roswell Park Cancer Institute
Buffalo
New York
United States
14263

Status

Recruiting

Source

Roswell Park Cancer Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:27-0400

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