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Vorinostat in Treating Women With Ductal Carcinoma in Situ of the Breast
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), July 2009
First Received: November 7, 2008   Last Updated: July 22, 2009   History of Changes
Sponsor: UCSF Helen Diller Family Comprehensive Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00788112
  Purpose

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 Intervention
Breast Cancer
Drug: vorinostat
Genetic: protein expression analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label
Official Title: A Window Trial of Vorinostat in Patients With Ductal Carcinoma in Situ (DCIS) of the Breast

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Reduction in Ki-67 compared to baseline Ki-67 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in HDAC1 and HDAC6 expression and histone H4 and α-tubulin acetylation in breast tissue and serum samples [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: July 2009
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00788112

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi     877-827-3222        
Sponsors and Collaborators
UCSF Helen Diller Family Comprehensive Cancer Center
Investigators
Principal Investigator: E. Shelley Hwang, MD UCSF Helen Diller Family Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: UCSF Helen Diller Family Comprehensive Cancer Center ( E. Shelley Hwang )
Study ID Numbers: CDR0000617655, UCSF-077532, H10367-31833, UCSF-07031833
Study First Received: November 7, 2008
Last Updated: July 22, 2009
ClinicalTrials.gov Identifier: NCT00788112     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
ductal breast carcinoma in situ

Additional relevant MeSH terms:
Anticarcinogenic Agents
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Sensory System Agents
Carcinoma in Situ
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Breast Diseases
Neoplasms by Histologic Type
Skin Diseases
Vorinostat
Breast Neoplasms
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions
Carcinoma
Carcinoma, Ductal
Neoplasms
Analgesics, Non-Narcotic
Carcinoma, Ductal, Breast
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Ductal, Lobular, and Medullary
Peripheral Nervous System Agents
Adenocarcinoma
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2009