Vorinostat and Bortezomib in Treating Patients With Progressive, Recurrent Glioblastoma Multiforme

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
• therapeutic conventional surgery — PROCEDURE
  Patient undergoes surgery
• bortezomib — DRUG
  Given IV

Study Details

This phase II trial is studying how well giving vorinostat together with bortezomib works in treating patients with progressive, recurrent glioblastoma multiforme. 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

Jul 31, 2008

Status verified

Oct 2011

Primary completion

Jul 31, 2010

Completion

Nov 30, 2010

Study Design

Enrollment

44 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Stratum 1 (not undergoing surgery)
  Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Stratum 2 (undergoing surgery)
  Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.

Primary Outcome Measure

Progression-free Survival at 6 Months [ Time Frame: At 6 months ]

Locations (214)

Find similar trials in Scottsdale, AZ

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