Status:
COMPLETED
Vorinostat in Treating Patients With Progressive or 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 vorinostat works in treating patients with progressive or recurrent glioblastoma multiforme. Drugs used in chemotherapy, such as vorinostat, work in different ...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the efficacy of vorinostat (SAHA), in terms of 6-month progression-free survival, in patients with progressive or recurrent glioblastoma multiforme. II. Determine th...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00238303
Start Date
September 1 2005
End Date
March 1 2010
Last Update
May 23 2014
Active Locations (1)
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1
North Central Cancer Treatment Group
Rochester, Minnesota, United States, 55905