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| Sponsor: | Sidney Kimmel Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Sidney Kimmel Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00262834 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: vorinostat Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase II |
| Study Type: | Interventional |
| 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 |
| Estimated Enrollment: | 25 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | December 2011 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Endocrine therapy
Radiotherapy
Other
Contacts and Locations| 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 |
More Information
| Responsible Party: | Vered Stearns, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| ClinicalTrials.gov Identifier: | NCT00262834 History of Changes |
| Other Study ID Numbers: | J0504 CDR0000445404, U01CA070095, P30CA006973, JHOC-J0504, NCI-6914 |
| Study First Received: | December 6, 2005 |
| Last Updated: | July 19, 2011 |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
|
stage I breast cancer stage II breast cancer stage III breast cancer |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Vorinostat |
Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |