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

NCT ID: NCT00262834

Last Updated: 2020-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2013-05-31

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.

Conditions

Breast Cancer; Stage I Breast Cancer; Stage II Breast Cancer; Stage III Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

Patients receive oral vorinostat twice daily on days -3 to 0. Approximately 2 hours after the final dose of vorinostat, patients undergo conventional surgery of the tumor on day 0. After completion of study treatment, patients are followed for 30 days.

Group Type: EXPERIMENTAL

vorinostat

Intervention Type: DRUG

Given orally, conventional surgery to follow.

conventional surgery

Intervention Type: OTHER

Undergo conventional surgery

Interventions

vorinostat

Given orally, conventional surgery to follow.

Intervention Type: DRUG

conventional surgery

Undergo conventional surgery

Intervention Type: OTHER

Other Intervention Names

L-001079038; SAHA; suberoylanilide hydroxamic acid; Zolinza; surgery, conventional

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vered Stearns

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University/Sidney Kimmel Cancer Center

Locations

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NCI-2009-00098

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000445404

Identifier Type: OTHER

Identifier Source: secondary_id

SKCCC J0504

Identifier Type: OTHER

Identifier Source: secondary_id

6914

Identifier Type: OTHER

Identifier Source: secondary_id

U01CA070095

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA006973

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2009-00098

Identifier Type: -

Identifier Source: org_study_id