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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
vorinostat
protein expression analysis
immunohistochemistry staining method
laboratory biomarker analysis
neoadjuvant therapy
therapeutic conventional surgery
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring ductal breast carcinoma in situ

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vorinostat

Arm Description

Outcomes

Primary Outcome Measures

Reduction in Ki-67 compared to baseline Ki-67

Secondary Outcome Measures

Changes in HDAC1 and HDAC6 expression and histone H4 and α-tubulin acetylation in breast tissue and serum samples

Full Information

First Posted
November 7, 2008
Last Updated
August 4, 2017
Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00788112
Brief Title
Vorinostat in Treating Women With Ductal Carcinoma in Situ of the Breast
Official Title
A Window Trial of Vorinostat in Patients With Ductal Carcinoma in Situ (DCIS) of the Breast
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
November 3, 2011 (Actual)
Study Completion Date
August 11, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
ductal breast carcinoma in situ

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vorinostat
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
vorinostat
Intervention Type
Genetic
Intervention Name(s)
protein expression analysis
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Primary Outcome Measure Information:
Title
Reduction in Ki-67 compared to baseline Ki-67
Time Frame
3 days prior to surgery
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Esserman, MD, MBA
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

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

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