Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Vered Stearns

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00262834
Information obtained from ClinicalTrials.gov on December 14, 2011

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