Vorinostat in Treating Women Who Are Undergoing Surgery For Newly Diagnosed Stage I, Stage II, or Stage III Breast Cancer
Recruitment status was Active, not recruiting
RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well vorinostat works in treating women who are undergoing surgery for newly diagnosed stage I, stage II, or stage III breast cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study Evaluating Surrogates of Response to Short Term Oral Suberoylanilide Hydroxamic Acid (SAHA) in Women With Newly Diagnosed Breast Cancer|
- Safety and tolerability after 3 days of treatment [ Time Frame: Baseline and after 3 day of SAHA ] [ Designated as safety issue: Yes ]
- Change in tissue apoptosis and proliferation after 3 days of treatment [ Time Frame: Baseline and after 3 day of SAHA ] [ Designated as safety issue: No ]
- Change in tissue histone acetylation after 3 days of treatment [ Time Frame: Baseline and after 3 day of SAHA ] [ Designated as safety issue: No ]
- Change in blood (peripheral blood mononuclear cells) histone acetylation after 3 days of treatment [ Time Frame: Baseline and after 3 day of SAHA ] [ Designated as safety issue: No ]
|Study Start Date:||January 2006|
|Estimated Study Completion Date:||December 2012|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
- Determine the safety and tolerability of vorinostat in women undergoing surgery for newly diagnosed stage I-III breast cancer.
OUTLINE: This is a multicenter, pilot study.
Patients receive oral vorinostat twice daily on days -3 to 0. Approximately 2 hours after the final dose of vorinostat, patients undergo surgical resection of the tumor on day 0.
After completion of study treatment, patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262834
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Study Chair:||Vered Stearns, MD||Sidney Kimmel Comprehensive Cancer Center|