Clinical trial NCT00262834: Vorinostat in Treating Women Who Are Undergoing Surgery For Newly Diagnosed Stage I -III Breast Cancer
Official title: A Pilot Study Evaluating Surrogates of Response to Short Term Oral Suberoylanilide Hydroxamic Acid (SAHA) in Women With Newly Diagnosed Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Stage I Breast Cancer
Stage II Breast Cancer
Stage III Breast Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2005-12-07
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients receive oral vorinostat twice daily on days -3 to 0. Approximately 2 hours after the final dose of vorinostat, patients undergo conventional surgical resection of the tumor on day 0. After completion of study treatment, patients are followed for 30 days.
Primary purpose: TREATMENT

Brief summary: 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. 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.

Detailed description: PRIMARY OBJECTIVE:

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

OULINE: 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.

Eligibility criteria: Inclusion Criteria:

* No prior or concurrent hormonal therapy for breast cancer
* 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
* ECOG 0-2 OR Karnofsky 60-100%
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin normal
* AST and ALT ≤ 2.5 times upper limit of normal
* PT ≤ 14 seconds
* Creatinine normal
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* 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
* At least 30 days since prior hormone replacement therapy (e.g., estrogen and/or progestin)
* Concurrent vaginal hormone preparations (e.g., vagifem or estring) allowed
* No concurrent birth control pills
* No prior radiotherapy to the ipsilateral breast
* No prior or concurrent radiotherapy for breast cancer
* 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 investigational agents
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent therapy for this cancer
* WBC ≥ 3,000/mm\^3

Exclusion criteria:

* Patients must not be recieving any other investigational agents
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to SAHA.
* Patients may not be taking valproic acid or another histone deacetylase inhibitor for at least 2 weeks prior to initiating SAHA.
* Women who are pregnant.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: After 3 days of vorinostat
measure: Change in Tissue Proliferation After 3 Days of Treatment
timeFrame: After 3 days of vorinostat
measure: Change in Tissue Apoptosis After 3 Days of Treatment
timeFrame: Baseline and after 3 day of vorinostat
Secondary outcomes:
measure: Change in Tissue Histone Acetylation After 3 Days of Treatment
timeFrame: Baseline and after 3 day of Vorinostat
measure: Change in Blood (Peripheral Blood Mononuclear Cells) Histone Acetylation After 3 Days of Treatment
timeFrame: Baseline and after 3 day of Vorinostat
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University/Sidney Kimmel Cancer Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University/Sidney Kimmel Cancer Center
name: Vered Stearns
role: PRINCIPAL_INVESTIGATOR
References: