Text Size

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.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00262834
First received: December 6, 2005
Last updated: June 6, 2012
Last verified: June 2012
History of Changes
  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
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: 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:

Drug Information available for: Vorinostat
U.S. FDA Resources

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

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

Secondary Outcome Measures:
  • Change in tissue histone acetylation after 3 days of treatment [ Time Frame: Baseline and after 3 day of SAHA ] [ Designated as safety issue: No ]
  • Change in blood (peripheral blood mononuclear cells) histone acetylation after 3 days of treatment [ Time Frame: Baseline and after 3 day of SAHA ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: January 2006
Estimated Study Completion Date: December 2012
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: vorinostat
    SAHA 300 mg capsules, orally, twice a day for 3 days
    Procedure: conventional surgery
    lumpectomy or mastectomy with or without axillary nodal evaluation
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
National Cancer Institute (NCI)
Investigators
Study Chair: Vered Stearns, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

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

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00262834     History of Changes
Other Study ID Numbers: J0504 CDR0000445404, U01CA070095, P30CA006973, JHOC-J0504, NCI-6914
Study First Received: December 6, 2005
Last Updated: June 6, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
stage I breast cancer
stage II breast cancer
stage III breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vorinostat
 Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013