Vorinostat, Temozolomide, or Bevacizumab in Combination With Radiation Therapy Followed by Bevaci… (NCT01236560) | Clinical Trial Compass
CompletedPhase 2/3
Vorinostat, Temozolomide, or Bevacizumab in Combination With Radiation Therapy Followed by Bevacizumab and Temozolomide in Young Patients With Newly Diagnosed High-Grade Glioma
United States101 participantsStarted 2011-01-26
Plain-language summary
This randomized phase II/III trial is studying vorinostat, temozolomide, or bevacizumab to see how well they work compared with each other when given together with radiation therapy followed by bevacizumab and temozolomide in treating young patients with newly diagnosed high-grade glioma. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving vorinostat is more effective then temozolomide or bevacizumab when given together with radiation therapy in treating glioma.
Who can participate
Age range3 Years – 21 Years
SexALL
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Inclusion Criteria:
* Newly diagnosed high-grade glioma
* Anaplastic astrocytoma
* Glioblastomamultiforme
* Gliosarcoma
* Primary spinal cord malignant glioma allowed
* No oligodendroglioma oroligoastrocytoma
* Patient must have histological verification of diagnosis
* No M+ disease (defined as evidence of neuraxis dissemination)
* No positive CSF cytology
* ECOG performance status (PS) 0-2
* Karnofsky PS 50-100% (patients \> 16 years of age)
* Lansky PS 50-100% (patients ≤ 16 years of age)
* ANC ≥ 1,000/μL
* Platelet count ≥ 100,000/μL
* Hemoglobin ≥ 8.0 mg/dL (transfusion independent)
* Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR serum creatinine based on age and/or gender as follows:
* 0.4 mg/dL (1 month to \< 6 months of age)
* 0.5 mg/dL (6 months to \< 1 year of age)
* 0.6 mg/dL (1 to \< 2 years of age)
* 0.8 mg/dL (2 to \< 6 years of age)
* 1.0 mg/dL (6 to \< 10 years of age)
* 1.2 mg/dL (10 to \< 13 years of age)
* 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to \< 16 years of age)
* 1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age)
* Proteinuria \< 2+ OR urine; protein ratio (UPC) ≤ 0.5
* If UPC \> 0.5, a 24-hour urine protein should be obtained and level should be \< 1,000 mg of protein
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT \< 2.5 times ULN
* Serum albumin ≥ 2 g/dL
* PT INR ≤ 1.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective con…