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

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ClinicalTrials.gov Identifier: NCT00788112
Recruitment Status : Completed
First Posted : November 10, 2008
Last Update Posted : August 7, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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 with ductal carcinoma in situ of the breast.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: vorinostat Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery Phase 1

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 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Window Trial of Vorinostat in Patients With Ductal Carcinoma in Situ (DCIS) of the Breast
Study Start Date : July 2009
Primary Completion Date : November 3, 2011
Study Completion Date : August 11, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Vorinostat
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Vorinostat Drug: vorinostat Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery


Outcome Measures

Primary Outcome Measures :
  1. Reduction in Ki-67 compared to baseline Ki-67 [ Time Frame: 3 days prior to surgery ]

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00788112


Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
Investigators
Principal Investigator: Laura Esserman, MD, MBA University of California, San Francisco
More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00788112     History of Changes
Other Study ID Numbers: CDR0000617655
UCSF-077532
H10367-31833
UCSF-07031833
First Posted: November 10, 2008    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017

Keywords provided by University of California, San Francisco:
ductal breast carcinoma in situ

Additional relevant MeSH terms:
Carcinoma
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Breast Carcinoma In Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Vorinostat
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action