Vorinostat in Treating Patients With Progressive or 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 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 facts

Study ID

NCT00238303

Run by

National Cancer Institute (NCI)

People needed

103

Starts

2005-09-01

Expected to finish

2010-03-01

Last updated by the study team

2014-05-23

Who can join

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

You may qualify if…

• 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)

Where it is running

• North Central Cancer Treatment Group — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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