Vorinostat in Treating Women Who Are Undergoing Surgery For Newly Diagnosed Stage I, Stage II, or Stage III Breast Cancer

Condition(s) targeted: Breast Cancer

Intervention: vorinostat (Drug); conventional surgery (Procedure); enzyme inhibitor therapy (Procedure); neoadjuvant therapy (Procedure)

Phase: Phase 2

Status: Recruiting

Sponsored by: Sidney Kimmel Comprehensive Cancer Center

Official(s) and/or principal investigator(s):
Vered Stearns, MD, Study Chair, Affiliation: Sidney Kimmel Comprehensive Cancer Center

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.

Official title: A Pilot Study Evaluating Surrogates of Response to Short Term Oral Suberoylanilide Hydroxamic Acid (SAHA) in Women With New Diagnosed Breast Cancer

Study design: Treatment

Primary outcome:

Safety and tolerability after 3 days of treatment

Change in tissue apoptosis and proliferation after 3 days of treatment

Secondary outcome:

Change in tumor morphology and proteins after 3 days of treatment

Change in tissue histone acetylation after 3 days of treatment

Change in blood (peripheral blood mononuclear cells) histone acetylation after 3 days of treatment

Detailed description: OBJECTIVES: Determine the safety and tolerability of vorinostat in women undergoing surgery for newly diagnosed stage I-III breast cancer. OUTLINE: This is a 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

DISEASE CHARACTERISTICS: Histologically confirmed breast cancer Stage I-III disease Scheduled to undergo definitive surgery or other primary treatment (e. g., preoperative/neoadjuvant systemic treatment) for breast cancer Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Sex Female Menopausal status Not specified Performance status ECOG 0-2 OR Karnofsky 60-100% Life expectancy Not specified Hematopoietic WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin normal AST and ALT ≤ 2. 5 times upper limit of normal PT ≤ 14 seconds Renal Creatinine normal Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No other uncontrolled intercurrent illness No history of allergic reaction attributed to compounds of similar chemical or biologic composition to vorinostat PRIOR CONCURRENT THERAPY: Chemotherapy No prior or concurrent chemotherapy for breast cancer Endocrine therapy At least 30 days since prior hormone replacement therapy (e. g., estrogen and/or progestin) No prior or concurrent hormonal therapy for breast cancer Concurrent vaginal hormone preparations (e. g., vagifem or estring) allowed No concurrent birth control pills Radiotherapy No prior radiotherapy to the ipsilateral breast No prior or concurrent radiotherapy for breast cancer Other No prior or concurrent novel therapy for breast cancer At least 14 days since prior valproic acid or another histone deacetylase inhibitor No other concurrent therapy for this cancer No other concurrent investigational agents No concurrent combination antiretroviral therapy for HIV-positive patients

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231-2410, United States; Recruiting
Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce, Phone: 410-955-8804, Email: jhcccro@jhmi.edu

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: January 2006
Last updated: December 25, 2007