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Vorinostat in Treating Women Who Are Undergoing Surgery For Newly Diagnosed Stage I, Stage II, or Stage III Breast Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), January 2007
Sponsors and Collaborators: Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00262834
  Purpose

RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well vorinostat works in treating women who are undergoing surgery for newly diagnosed stage I, stage II, or stage III breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: vorinostat
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Suberoylanilide hydroxamic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Pilot Study Evaluating Surrogates of Response to Short Term Oral Suberoylanilide Hydroxamic Acid (SAHA) in Women With New Diagnosed Breast Cancer

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

Primary Outcome Measures:
  • Safety and tolerability after 3 days of treatment [ Designated as safety issue: Yes ]
  • Change in tissue apoptosis and proliferation after 3 days of treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in tumor morphology and proteins after 3 days of treatment [ Designated as safety issue: No ]
  • Change in tissue histone acetylation after 3 days of treatment [ Designated as safety issue: No ]
  • Change in blood (peripheral blood mononuclear cells) histone acetylation after 3 days of treatment [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: January 2006
Estimated Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the safety and tolerability of vorinostat in women undergoing surgery for newly diagnosed stage I-III breast cancer.

OUTLINE: This is a multicenter, pilot study.

Patients receive oral vorinostat twice daily on days -3 to 0. Approximately 2 hours after the final dose of vorinostat, patients undergo surgical resection of the tumor on day 0.

After completion of study treatment, patients are followed for 30 days.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer

    • Stage I-III disease
    • Scheduled to undergo definitive surgery or other primary treatment (e.g., preoperative/neoadjuvant systemic treatment) for breast cancer
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • Not specified

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal
  • PT ≤ 14 seconds

Renal

  • Creatinine normal

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled intercurrent illness
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to vorinostat

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • No prior or concurrent chemotherapy for breast cancer

Endocrine therapy

  • At least 30 days since prior hormone replacement therapy (e.g., estrogen and/or progestin)
  • No prior or concurrent hormonal therapy for breast cancer
  • Concurrent vaginal hormone preparations (e.g., vagifem or estring) allowed
  • No concurrent birth control pills

Radiotherapy

  • No prior radiotherapy to the ipsilateral breast
  • No prior or concurrent radiotherapy for breast cancer

Other

  • No prior or concurrent novel therapy for breast cancer
  • At least 14 days since prior valproic acid or another histone deacetylase inhibitor
  • No other concurrent therapy for this cancer
  • No other concurrent investigational agents
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262834

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231-2410
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce     410-955-8804     jhcccro@jhmi.edu    
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Study Chair: Vered Stearns, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000445404, JHOC-J0504, NCI-6914
Study First Received: December 6, 2005
Last Updated: October 22, 2008
ClinicalTrials.gov Identifier: NCT00262834  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
stage III breast cancer

Study placed in the following topic categories:
Skin Diseases
Vorinostat
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Anticarcinogenic Agents
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009