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

Completed · Phase 2

Conditions studied: Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor

In brief

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 facts

Study ID

NCT00641706

Run by

National Cancer Institute (NCI)

People needed

44

Starts

2008-07-01

Expected to finish

2010-11-01

Last updated by the study team

2014-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed glioblastoma multiforme
• Gliosarcoma or other grade 4 astrocytoma variant (e.g., giant cell glioblastoma) allowed
• Recurrent disease
• Must have evidence of tumor progression by MRI or CT scan after radiotherapy or after the most recent antitumor therapy
• Bidimensionally measurable or evaluable disease by MRI or CT scan
• Patients receiving corticosteroids must be on a fixed dose for at least 1 week prior to baseline scan
• ECOG performance status 0-2
• WBC ≥ 3,000/mm³
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9 g/dL
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST ≤ 3 times ULN
• Creatinine normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 6 months after the last dose of vorinostat
• Willing to provide mandatory correlative laboratory tissue samples
• Able to take oral medications
• No uncontrolled infection
• No known hypersensitivity to any of the components of vorinostat or bortezomib
• No myocardial infarction or unstable angina within the past 6 months
• No congestive heart failure requiring use of ongoing maintenance therapy or history of life-threatening ventricular arrhythmias
• No concurrent uncontrolled illness including, but not limited to, any of the following:
• Ongoing or active infection

Where it is running

• The Medical Center of Aurora — Aurora, Colorado, United States
• Boulder Community Hospital — Boulder, Colorado, United States
• Penrose-Saint Francis Healthcare — Colorado Springs, Colorado, United States
• Porter Adventist Hospital — Denver, Colorado, United States
• Exempla Saint Joseph Hospital — Denver, Colorado, United States
• Presbyterian - Saint Lukes Medical Center - Health One — Denver, Colorado, United States
• Rose Medical Center — Denver, Colorado, United States
• Colorado Cancer Research Program CCOP — Denver, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• Saint Mary's Hospital and Regional Medical Center — Grand Junction, Colorado, United States
• North Colorado Medical Center — Greeley, Colorado, United States
• Saint Anthony Hospital — Lakewood, Colorado, United States
• Sky Ridge Medical Center — Lone Tree, Colorado, United States
• Longmont United Hospital — Longmont, Colorado, United States
• McKee Medical Center — Loveland, Colorado, United States
• Saint Mary Corwin Medical Center — Pueblo, Colorado, United States
• North Suburban Medical Center — Thornton, Colorado, United States
• Exempla Lutheran Medical Center — Wheat Ridge, Colorado, United States
• Mayo Clinic in Florida — Jacksonville, Florida, United States
• Rush - Copley Medical Center — Aurora, Illinois, United States
• Illinois CancerCare-Bloomington — Bloomington, Illinois, United States
• Saint Joseph Medical Center — Bloomington, Illinois, United States
• Graham Hospital Association — Canton, Illinois, United States
• Illinois CancerCare-Canton — Canton, Illinois, United States
• Mayo Clinic in Arizona — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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