Vorinostat in Treating Women With Ductal Carcinoma in Situ of the Breast

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00788112
First received: November 7, 2008
Last updated: August 6, 2013
Last verified: August 2013

November 7, 2008
August 6, 2013
July 2009
July 2011   (final data collection date for primary outcome measure)
Reduction in Ki-67 compared to baseline Ki-67 [ Time Frame: 3 days prior to surgery ] [ Designated as safety issue: No ]
Reduction in Ki-67 compared to baseline Ki-67 [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00788112 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Changes in HDAC1 and HDAC6 expression and histone H4 and α-tubulin acetylation in breast tissue and serum samples [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Vorinostat in Treating Women With Ductal Carcinoma in Situ of the Breast
A Window Trial of Vorinostat in Patients With Ductal Carcinoma in Situ (DCIS) of the Breast

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Breast Cancer
  • Drug: vorinostat
  • Genetic: protein expression analysis
  • Other: immunohistochemistry staining method
  • Other: laboratory biomarker analysis
  • Procedure: neoadjuvant therapy
  • Procedure: therapeutic conventional surgery
Experimental: Vorinostat
Interventions:
  • Drug: vorinostat
  • Genetic: protein expression analysis
  • Other: immunohistochemistry staining method
  • Other: laboratory biomarker analysis
  • Procedure: neoadjuvant therapy
  • Procedure: therapeutic conventional surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
17
December 2013
July 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00788112
CDR0000617655, UCSF-077532, H10367-31833, UCSF-07031833
Yes
University of California, San Francisco
University of California, San Francisco
National Cancer Institute (NCI)
Principal Investigator: Laura Esserman, MD, MBA University of California, San Francisco
University of California, San Francisco
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP