Vorinostat and Trastuzumab in Treating Patients With Metastatic or Locally Recurrent Breast Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00258349
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Breast Cancer
  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer

Eligibility Criteria

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

Interventions

  • vorinostat — DRUG
    Given orally
  • trastuzumab — DRUG
    Given IV

Study Details

This phase I/II trial is studying the side effects and best dose of vorinostat when given together with trastuzumab and to see how well they work in treating patients with metastatic breast canceror breast cancer that has recurred in the chest wall. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Vorinostat and trastuzumab also may stop the growth of tumor cells by blocking blood flow to the tumor. Giving vorinostat together with trastuzumab may be a better way to block tumor growth.

Key Dates

Start date
Aug 31, 2006
Status verified
Oct 2013
Primary completion
Aug 31, 2010
Completion
Sep 30, 2010

Study Design

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

Arms

  • Experimental: Arm I
    Patients will receive vorinostat by mouth twice a day for 2 weeks. They will also receive a 90-minute infusion of trastuzumab in week 1.

Primary Outcome Measure

Response Rate [ Time Frame: Tumor assessment was obtained at baseline, after 6 weeks (week 6 = last week of Cycle 2), and after every 4 cycles of therapy ]

Locations (25)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
Iowa Lutheran HospitalDes MoinesIowa50316-
Iowa Methodist Medical CenterDes MoinesIowa50309-
Iowa Oncology Research Association CCOPDes MoinesIowa50309-
Medical Oncology and Hematology AssociatesDes MoinesIowa50314-
Medical Oncology and Hematology Associates-Des MoinesDes MoinesIowa50309-
Mercy CapitolDes MoinesIowa50307-
Mercy Medical Center - Des MoinesDes MoinesIowa50314-
Mercy Medical Center-Sioux CitySioux CityIowa51104-
Saint Luke's Regional Medical CenterSioux CityIowa51104-
Siouxland Hematology Oncology AssociatesSioux CityIowa51101-
Johns Hopkins UniversityBaltimoreMaryland21287-8936-
Eastern Cooperative Oncology GroupBostonMassachusetts02215-
Hutchinson Area Health CareHutchinsonMinnesota55350-
Meeker County Memorial HospitalLitchfieldMinnesota55355-
Saint John's Hospital - HealtheastMaplewoodMinnesota55109-
Hennepin County Medical CenterMinneapolisMinnesota55415-
Virginia Piper Cancer InstituteMinneapolisMinnesota55407-
Regions HospitalSaint PaulMinnesota55101-
Saint Joseph's Hospital - HealtheastSaint PaulMinnesota55102-
Saint Francis Regional Medical CenterShakopeeMinnesota55379-
Woodwinds Health CampusWoodburyMinnesota55125-
Saint Vincent's Hospital and Medical Center of New YorkNew YorkNew York10011-
Albert Einstein College of MedicineThe BronxNew York10461-
Montefiore Medical CenterThe BronxNew York10467-2490-

Find similar trials in Birmingham, AL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Alabama at Birmingham· Birmingham, ALIowa Lutheran Hospital· Des Moines, IAIowa Methodist Medical Center· Des Moines, IAIowa Oncology Research Association CCOP· Des Moines, IAMedical Oncology and Hematology Associates· Des Moines, IAMedical Oncology and Hematology Associates-Des Moines· Des Moines, IA

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