Status:
COMPLETED
Vorinostat in Treating Women With Ductal Carcinoma in Situ of the Breast
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-120 years
Phase:
PHASE1
Brief Summary
RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This clinical trial is studying how well vorinostat works in treating women w...
Detailed Description
OBJECTIVES: * To evaluate the in vivo molecular and biological effects of vorinostat by analyzing changes in proliferation and apoptosis, histone acetylation, and HDAC protein expression in women wit...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed (by core biopsy) ductal carcinoma in situ
- Stage 0 disease
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Menopausal status not specified
- ECOG performance status 0-2
- ANC ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9 g/dL
- Potassium and magnesium levels normal
- Prothrombin time or INR ≤ 1.5 times upper limit of normal (ULN) (unless the patient is receiving therapeutic anticoagulation)
- Partial thromboplastin time ≤ 1.2 times ULN (unless the patient is receiving therapeutic anticoagulation)
- Serum creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 effective barrier methods of contraception
- No known psychiatric or substance abuse disorder that would preclude cooperation with the study requirements
- No active hepatitis A, B, or C infection
- No active HIV infection
- No other active infection
- No other malignancy within the past 5 years
- No condition that would interfere with the absorption or intake of vorinostat
- No history or current evidence of any condition or laboratory abnormality that would confound study results, interfere with the patient's participation in the full duration of the study, or that would not be in the best interest of the patient to participate
- PRIOR CONCURRENT THERAPY:
- More than 2 weeks since prior IV antibiotics, antivirals, or antifungals
- No prior gastrointestinal surgery or other procedure that would interfere with the absorption or intake of vorinostat
- No prior or concurrent therapy with any other HDAC inhibitor, including valproic acid
- No prior treatment with any other investigational agent
- No concurrent systemic steroids
- No concurrent anticancer chemotherapy, radiotherapy, biological therapy, or other investigational therapy
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2015
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00788112
Start Date
July 1 2009
End Date
August 11 2015
Last Update
August 7 2017
Active Locations (1)
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1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115