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

NCT ID: NCT00788112

Last Updated: 2017-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2015-08-11

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Vorinostat

Group Type: EXPERIMENTAL

vorinostat

Intervention Type: DRUG

protein expression analysis

Intervention Type: GENETIC

immunohistochemistry staining method

Intervention Type: OTHER

laboratory biomarker analysis

Intervention Type: OTHER

neoadjuvant therapy

Intervention Type: PROCEDURE

therapeutic conventional surgery

Intervention Type: PROCEDURE

Interventions

vorinostat

Intervention Type: DRUG

protein expression analysis

Intervention Type: GENETIC

immunohistochemistry staining method

Intervention Type: OTHER

laboratory biomarker analysis

Intervention Type: OTHER

neoadjuvant therapy

Intervention Type: PROCEDURE

therapeutic conventional surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Esserman, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Countries

United States

Other Identifiers

UCSF-077532

Identifier Type: -

Identifier Source: secondary_id

H10367-31833

Identifier Type: -

Identifier Source: secondary_id

UCSF-07031833

Identifier Type: -

Identifier Source: secondary_id

CDR0000617655

Identifier Type: -

Identifier Source: org_study_id