Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT01108003
Study type Interventional
Source Roswell Park Cancer Institute
Contact
Status Terminated
Phase N/A
Start date April 2010
Completion date October 2015

See also
  Status Clinical Trial Phase
Completed NCT02897765 - A Personal Cancer Vaccine (NEO-PV-01) w/ Nivolumab for Patients With Melanoma, Lung Cancer or Bladder Cancer Phase 1
Terminated NCT01118351 - Sunitinib Malate in Treating Patients With Recurrent Transitional Cell Bladder Cancer Phase 2
Terminated NCT00112905 - Sorafenib in Treating Patients With Regional or Metastatic Cancer of the Urothelium Phase 2
Completed NCT00072150 - Phase II Trial Of PS-341 (Bortezomib) In Patients With Previously Treated Advanced Urothelial Tract Transitional Cell Carcinoma Phase 2
Completed NCT00028756 - Comparison of Immediate and Delayed Adjuvant Chemotherapy in Treating Patients Who Have Undergone a Radical Cystectomy for Stage III or Stage IV Transitional Cell Carcinoma of the Bladder Urothelium Phase 3
Completed NCT02318329 - Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors Phase 1
Completed NCT00407485 - VEGF Trap in Treating Patients With Recurrent, Locally Advanced, or Metastatic Cancer of the Urothelium Phase 2
Withdrawn NCT01639521 - Gemcitabine Hydrochloride and Cisplatin or High-Dose Methotrexate, Vinblastine, Doxorubicin Hydrochloride, and Cisplatin in Treating Patients With Urothelial Cancer Phase 2
Completed NCT00003167 - Gene Therapy in Treating Patients With Advanced Bladder Cancer Phase 1
Completed NCT03081858 - Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer Phase 1/Phase 2
Completed NCT02101931 - A Laser Detection for Bladder Cancer by (Photodynamic) Spectra of Urine Phase 3
Terminated NCT00859339 - Neoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy for TCC Phase 2
Completed NCT00005831 - Trastuzumab and Combination Chemotherapy in Treating Patients With Locally Recurrent or Metastatic Urinary Tract Cancer Phase 2
Completed NCT00706641 - Neoadjuvant Dasatinib and Radical Cystectomy for Transitional Cell Carcinoma of the Bladder N/A
Terminated NCT00363883 - Vorinostat in Treating Patients With Locally Recurrent or Metastatic Cancer of the Urothelium Phase 2
Completed NCT01824329 - Prostate Capsule Sparing Cystectomy and Nerve-sparing Radical Cystoprostatectomy in Men With Bladder Cancer Phase 2
Completed NCT00021099 - Ixabepilone in Treating Patients With Advanced Urinary Tract Cancer Phase 2
Terminated NCT01382706 - Docetaxel and Lapatinib in Metastatic Transitional Cell Carcinoma in Bladder Phase 2
Terminated NCT01954173 - Adjuvant Radiation for High Risk Bladder Cancer N/A
Terminated NCT00004856 - Trastuzumab in Treating Patients With Previously Treated, Locally Advanced, or Metastatic Cancer of the Urothelium Phase 2