Full Text View
Tabular View
No Study Results Posted
Related Studies
Vorinostat in Treating Women Who Are Undergoing Surgery For Newly Diagnosed Stage I, Stage II, or Stage III Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: December 6, 2005   Last Updated: November 5, 2009   History of Changes
Sponsor: Sidney Kimmel Comprehensive Cancer Center
Collaborator: 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

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 Newly Diagnosed Breast Cancer

Resource links provided by NLM:


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: December 2008 (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
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Study Chair: Vered Stearns, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Vered Stearns )
Study ID Numbers: CDR0000445404, JHOC-J0504, NCI-6914
Study First Received: December 6, 2005
Last Updated: November 5, 2009
ClinicalTrials.gov Identifier: NCT00262834     History of Changes
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Anticarcinogenic Agents
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Vorinostat
Physiological Effects of Drugs
Breast Neoplasms
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
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010