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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00262834
Phase
PHASE2
Status
Completed

Conditions

  • Breast Cancer
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage III Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • vorinostat — DRUG
    Given orally, conventional surgery to follow.
  • conventional surgery — OTHER
    Undergo conventional surgery

Study Details

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.

Key Dates

Start date
Oct 31, 2005
Status verified
Feb 2020
Primary completion
Oct 31, 2008
Completion
May 31, 2013

Study Design

Enrollment
54 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Number of Participants With Adverse Events [ Time Frame: After 3 days of vorinostat ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-

Find similar trials in Baltimore, MD

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Johns Hopkins University/Sidney Kimmel Cancer Center· Baltimore, MD

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