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A Pilot Study Evaluating Surrogates of Response to Short Term Oral Suberoylanilide Hydroxamic Acid (SAHA) in Women With Newly Diagnosed Breast Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

A Pilot Study Evaluating Surrogates of Response to Short Term Oral Suberoylanilide Hydroxamic Acid (SAHA) in Women With Newly Diagnosed Breast Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability after 3 days of treatment

Outcome Time Frame:

Baseline and after 3 day of SAHA

Safety Issue:

Yes

Principal Investigator

Vered Stearns, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

J0504 CDR0000445404

NCT ID:

NCT00262834

Start Date:

January 2006

Completion Date:

December 2012

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage III breast cancer
  • Breast Neoplasms

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410