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Status:

COMPLETED

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

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Adult Giant Cell Glioblastoma

Adult Glioblastoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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 t...

Detailed Description

PRIMARY OBJECTIVES: I. To determine the clinical efficacy of vorinostat (SAHA) and bortezomib, in terms of progression-free survival (PFS) at 6 months, in patients with progressive, recurrent gliobla...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • 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
  • Psychiatric illness or social situation that would limit compliance with study requirements
  • No other active malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No comorbid systemic illness or other severe concurrent disease that, in the judgment of the investigator, would preclude study entry or significantly interfere with proper assessment of safety and toxicity of the prescribed study regimens
  • Not immunocompromised
  • Patients known to be HIV positive are eligible provided there is no clinical evidence of an immunocompromised state
  • No peripheral neuropathy ≥ grade 2
  • No peripheral neuropathy with pain ≥ grade 1
  • No congenital long QT syndrome
  • No prolonged OTC interval (\> 450 msec)
  • No other concurrent anticancer therapy (other than hormonal therapy)
  • At least 8 weeks since prior radiotherapy
  • More than 6 weeks since prior stereotactic radiosurgery or interstitial brachytherapy, unless there is a separate lesion on MRI that is not part of the prior treatment field
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  • No more than 1 prior chemotherapy regimen\* for progressive/recurrent disease (stratum 1)
  • Patients in stratum 2 may have received any number of prior chemotherapy regimens\* for progressive/recurrent disease
  • More than 2 weeks since prior small molecule cell cycle inhibitors
  • More than 7 days since prior valproic acid
  • More than 7 days since prior category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including:
  • Quinidine, procainamide, disopyramide
  • Amiodarone, sotalol, ibutilide, dofetilide
  • Erythromycin, clarithromycin
  • Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide
  • Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin,lidoflazine
  • More than 4 weeks since prior bevacizumab
  • No prior treatment with vorinostat or bortezomib
  • No concurrent enzyme-inducing antiepileptic drugs (e.g., phenytoin,fosphenytoin, carbamazepine, phenobarbital, or primidone)
  • No other concurrent potent CYP3A4 inducer (e.g., rifampin or St. John's wort)
  • No other concurrent investigational therapy for the primary neoplasm

Exclusion

    Key Trial Info

    Start Date :

    July 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 1 2010

    Estimated Enrollment :

    44 Patients enrolled

    Trial Details

    Trial ID

    NCT00641706

    Start Date

    July 1 2008

    End Date

    November 1 2010

    Last Update

    May 14 2014

    Active Locations (214)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 54 (214 locations)

    1

    Mayo Clinic in Arizona

    Scottsdale, Arizona, United States, 85259

    2

    The Medical Center of Aurora

    Aurora, Colorado, United States, 80012

    3

    Boulder Community Hospital

    Boulder, Colorado, United States, 80301

    4

    Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, United States, 80907