Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments vorinostat, conventional surgery
Phase phase 2
Target HDAC
Sponsor Sidney Kimmel Comprehensive Cancer Center
Collaborator National Cancer Institute (NCI)
Start date January 2006
End date October 2008
Trial size 25 participants
Trial identifier NCT00262834, J0504 CDR0000445404, JHOC-J0504, NCI-6914, P30CA006973, U01CA070095

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacodynamics study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Safety and tolerability after 3 days of treatment
time frame: Baseline and after 3 day of SAHA
Change in tissue apoptosis and proliferation after 3 days of treatment
time frame: Baseline and after 3 day of SAHA

Secondary Outcomes

Measure
Change in tissue histone acetylation after 3 days of treatment
time frame: Baseline and after 3 day of SAHA
Change in blood (peripheral blood mononuclear cells) histone acetylation after 3 days of treatment
time frame: Baseline and after 3 day of SAHA

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title A Pilot Study Evaluating Surrogates of Response to Short Term Oral Suberoylanilide Hydroxamic Acid (SAHA) in Women With Newly Diagnosed Breast Cancer
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center.