Vorinostat in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00238303
Phase
PHASE2
Status
Completed

Conditions

  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Recurrent Adult Brain Tumor

Eligibility Criteria

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

Interventions

  • vorinostat — DRUG
    Given orally
  • conventional surgery — PROCEDURE
    Patients undergo surgery to remove tumor

Study Details

This phase II trial is studying how well vorinostat works in treating patients with progressive or recurrent glioblastoma multiforme. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any remaining tumor cells.

Key Dates

Start date
Sep 30, 2005
Status verified
Oct 2011
Primary completion
Jul 31, 2008
Completion
Mar 31, 2010

Study Design

Enrollment
103 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Stratum 1 (not undergoing surgery)
    Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
  • Experimental: Stratum 2 (undergoing surgery)
    Beginning 3 days prior to surgery, patients receive oral SAHA once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Proportion of Successes (Patients Alive and Progression-free) [ Time Frame: At 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
North Central Cancer Treatment GroupRochesterMinnesota55905-

Find similar trials in Rochester, MN

By research site
North Central Cancer Treatment Group· Rochester, MN

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