Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments vorinostat, protein expression analysis, immunohistochemistry staining method, laboratory biomarker analysis, neoadjuvant therapy, therapeutic conventional surgery
Phase phase 1
Target HDAC
Sponsor University of California, San Francisco
Collaborator National Cancer Institute (NCI)
Start date July 2009
End date July 2011
Trial size 17 participants
Trial identifier NCT00788112, CDR0000617655, H10367-31833, UCSF-07031833, UCSF-077532

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 with ductal carcinoma in situ of the breast.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model single group assignment
Masking open label
Arm
(Experimental)
vorinostat
protein expression analysis
immunohistochemistry staining method
laboratory biomarker analysis
neoadjuvant therapy
therapeutic conventional surgery

Primary Outcomes

Measure
Reduction in Ki-67 compared to baseline Ki-67
time frame: 3 days prior to surgery

Secondary Outcomes

Measure
Changes in HDAC1 and HDAC6 expression and histone H4 and α-tubulin acetylation in breast tissue and serum samples
time frame: 3 days prior to surgery

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title A Window Trial of Vorinostat in Patients With Ductal Carcinoma in Situ (DCIS) of the Breast
Principal investigator Laura Esserman, MD, MBA
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 with ductal carcinoma in situ of the breast. OUTLINE: Patients receive oral vorinostat twice a day for 3 days in the absence of unacceptable toxicity. Patients then undergo lumpectomy or mastectomy 2 hours after the last dose of vorinostat. Blood and tissue samples are collected at baseline and during surgery for biomarker laboratory studies. Samples are analyzed by immunohistochemistry for Ki-67, HDAC1 and HDAC6 protein expression, and histone H4 and α-tubulin acetylation. After completion of study therapy, patients are followed for 1 month and then every 6 months for 5 years.
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by University of California, San Francisco.