Vorinostat in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
Condition: Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Recurrent Adult Brain Tumor
MeSH terms: Glioblastoma; Gliosarcoma; Recurrence
Intervention: vorinostat; conventional surgery
Intervention description: Given orally; Patients undergo surgery to remove tumor
Intervention MeSH terms: Vorinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed grade 4 astrocytoma (glioblastoma multiforme), including
             gliosarcoma, at primary diagnosis or recurrence

               -  Progressive or recurrent disease

          -  Measurable or evaluable disease by MRI or CT scan

          -  Performance status - ECOG 0-2

          -  WBC ≥ 3,000/mm^3

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 8 g/dL

          -  AST ≤ 3 times upper limit of normal (ULN)

          -  Bilirubin normal

          -  Creatinine ≤ 1.5 times ULN

          -  No myocardial infarction within the past 6 months

          -  No congestive heart failure

          -  No life-threatening ventricular arrhythmia requiring ongoing maintenance therapy

          -  No known HIV positivity

          -  Not immunocompromised except if related to the use of corticosteroids

          -  No known hypersensitivity to any of the components of the study drug

          -  No uncontrolled infection

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 6 months after
             completion of study treatment

          -  No other malignancy

          -  No other severe disease that would preclude study participation

          -  Prior adjuvant chemotherapy allowed

          -  More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

          -  More than 2 weeks since prior small molecule cell cycle inhibitor

          -  Concurrent corticosteroids allowed as long as dose has been stable for ≥ 1 week

          -  At least 8 weeks since prior radiotherapy

               -  Must have evidence of tumor progression by MRI or CT scan after radiotherapy

          -  More than 6 weeks since prior stereotactic radiosurgery or interstitial brachytherapy,
             unless 1 of the following criteria is met:

               -  There is a separate lesion by MRI outside of the prior treatment field

               -  There is evidence of recurrent disease by biopsy, MRI spectroscopy, or
                  positron-emission tomography scan

          -  More than 2 weeks since prior valproic acid