Status:
COMPLETED
Vorinostat in Treating Women Who Are Undergoing Surgery For Newly Diagnosed Stage I -III Breast Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Stage I Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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. Vorinostat may stop the growth...
Detailed Description
PRIMARY OBJECTIVE: I. Determine the safety and tolerability of vorinostat in women undergoing conventional surgery for newly diagnosed stage I-III breast cancer. OULINE: This is a multicenter, pilot...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- No prior or concurrent hormonal therapy for breast cancer
- 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
- ECOG 0-2 OR Karnofsky 60-100%
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal
- PT ≤ 14 seconds
- Creatinine normal
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- 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
- At least 30 days since prior hormone replacement therapy (e.g., estrogen and/or progestin)
- Concurrent vaginal hormone preparations (e.g., vagifem or estring) allowed
- No concurrent birth control pills
- No prior radiotherapy to the ipsilateral breast
- No prior or concurrent radiotherapy for breast cancer
- 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 investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent therapy for this cancer
- WBC ≥ 3,000/mm\^3
- Exclusion criteria:
- Patients must not be recieving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to SAHA.
- Patients may not be taking valproic acid or another histone deacetylase inhibitor for at least 2 weeks prior to initiating SAHA.
- Women who are pregnant.
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00262834
Start Date
October 1 2005
End Date
May 1 2013
Last Update
February 19 2020
Active Locations (1)
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1
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287