A Pilot Study Evaluating Surrogates of Response to Short Term Oral Suberoylanilide Hydroxamic Acid (SAHA) in Women With Newly Diagnosed Breast Cancer
18 Years
N/A
Female
Breast Cancer
Trial Information
A Pilot Study Evaluating Surrogates of Response to Short Term Oral Suberoylanilide Hydroxamic Acid (SAHA) in Women With Newly Diagnosed Breast Cancer
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety and tolerability after 3 days of treatment
Outcome Time Frame:
Baseline and after 3 day of SAHA
Safety Issue:
Yes
Principal Investigator
Vered Stearns, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Sidney Kimmel Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
J0504 CDR0000445404
NCT ID:
NCT00262834
Start Date:
January 2006
Completion Date:
December 2012
Related Keywords:
- Breast Cancer
- stage I breast cancer
- stage II breast cancer
- stage III breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
