Vorinostat and Bortezomib in Treating Patients With Advanced Soft Tissue Sarcoma

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00937495
Phase
PHASE2
Status
Completed

Conditions

  • Recurrent Adult Soft Tissue Sarcoma
  • Stage III Adult Soft Tissue Sarcoma
  • Stage IV Adult Soft Tissue Sarcoma

Eligibility Criteria

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

Interventions

  • vorinostat — DRUG
    400 mg given PO
  • bortezomib — DRUG
    1.3 mg/m\^2 given IV

Study Details

This phase II trial is studying how well giving vorinostat together with bortezomib works in treating patients with advanced soft tissue sarcoma. Vorinostat and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat together with bortezomib may kill more tumor cells.

Key Dates

Start date
Jun 30, 2009
Status verified
Sep 2013
Primary completion
Aug 31, 2010
Completion
Jun 30, 2011

Study Design

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

Arms

  • Experimental: Treatment (vorinostat, bortezomib)
    Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m\^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Confirmed Tumor Responses [ Time Frame: Up to 2 years ]

Locations (6)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980-
Johns Hopkins UniversityBaltimoreMaryland21287-8936-
Mayo ClinicRochesterMinnesota55905-
Metro-Minnesota CCOPSaint Louis ParkMinnesota55416-
Washington University School of MedicineSt LouisMissouri63110-
University of Wisconsin Hospital and ClinicsMadisonWisconsin53792-

Find similar trials in Jacksonville, FL

By research site
Mayo Clinic in Florida· Jacksonville, FLJohns Hopkins University· Baltimore, MDMayo Clinic· Rochester, MNMetro-Minnesota CCOP· Saint Louis Park, MNWashington University School of Medicine· St Louis, MOUniversity of Wisconsin Hospital and Clinics· Madison, WI

Related Studies