Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Vorinostat in Treating Women Who Are Undergoing Surgery For Newly Diagnosed Stage I, Stage II, or Stage III Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	JHOC-J0504 J0504, 6914, NCI-6914, NCT00262834

Objectives

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

Entry 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

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

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/mm³
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

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

Expected Enrollment

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

Outcomes

Safety and tolerability after 3 days of treatment
Change in tissue apoptosis and proliferation after 3 days of treatment

Change in tumor morphology and proteins after 3 days of treatment
Change in tissue histone acetylation after 3 days of treatment
Change in blood (peripheral blood mononuclear cells) histone acetylation after 3 days of treatment

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.

Trial Contact Information

Trial Lead Organizations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Vered Stearns, MD, Protocol chair		Ph: 443-287-6489

Registry Information
Official Title		A Pilot Study Evaluating Surrogates of Response to Short Term Oral Suberoylanilide Hydroxamic Acid (SAHA) in Women with Newly Diagnosed Breast Cancer
Trial Start Date		2006-01-04
Trial Completion Date		2008-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00262834
Date Submitted to PDQ		2005-08-16
Information Last Verified		2009-07-05
NCI Grant/Contract Number		CA70095, CA06973

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