Status:
COMPLETED
Vorinostat, Temozolomide, or Bevacizumab in Combination With Radiation Therapy Followed by Bevacizumab and Temozolomide in Young Patients With Newly Diagnosed High-Grade Glioma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Brain Stem Glioma
Cerebral Astrocytoma
Eligibility:
All Genders
3-21 years
Phase:
PHASE2
PHASE3
Brief 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 bevaci...
Detailed Description
PRIMARY OBJECTIVES: I. To identify the dose of vorinostat that is feasible when given in combination with radiotherapy (RT) in patients with newly diagnosed high-grade gliomas (HGG). II. To compare 1...
Eligibility Criteria
Inclusion
- 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:
- 4 mg/dL (1 month to \< 6 months of age)
- 5 mg/dL (6 months to \< 1 year of age)
- 6 mg/dL (1 to \< 2 years of age)
- 8 mg/dL (2 to \< 6 years of age)
- 0 mg/dL (6 to \< 10 years of age)
- 2 mg/dL (10 to \< 13 years of age)
- 5 mg/dL (male) or 1.4 mg/dL (female) (13 to \< 16 years of age)
- 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 contraception during all study therapy and for ≥ 6 months after completion of bevacizumab
- Hypertension well controlled (≤ 95\^th percentile for age and height if patient is ≤ 17years) by stable doses of medication allowed
- For patients \> 17 years, systolic blood pressure (BP) ≤ 150 mm Hg or diastolic BP ≤ 100 mm Hg)
- Seizure disorder allowed provided patient is well-controlled and on nonenzyme-inducing anticonvulsants
- No history of myocardial infarction, severe or unstable angina, clinically significant peripheral vascular disease, ≥ grade 2 heart failure, or serious and inadequately controlled cardiac arrhythmia
- No known bleeding diathesis or coagulopathy
- No prior arterial thromboembolic events, including transient ischemic attacks orcerebrovascular accidents
- No prior diagnosis of a deep venous thrombosis, including pulmonary embolism, and no known thrombophilic condition (e.g., protein S, protein C, antithrombin III deficiency, Factor V Leiden or Factor II G202'0A mutation, homocysteinemia, or antiphospholipid antibody syndrome)
- No history of an abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- No serious or non-healing wound, ulcer, or bone fracture
- No evidence of significant postoperative intracranial hemorrhage, defined as \> 1 cm of blood on postoperative MRI scan (potentially in addition to the postoperative scan) obtained within the past 14days
- No history of allergic reaction to Chinese hamster ovary cell products or other recombinanthuman antibodies
- No more than 31 days since definitive surgery
- Must not have received any prior chemotherapy, radiotherapy, immunotherapy, or bone marrow transplant
- More than 7 days since major surgical procedure and recovered
- For patients scheduled to receive bevacizumab:
- More than 28 days since major procedure
- More than 14 days since intermediate procedure
- More than 7 days since minor procedure (lumbar picture or placement of PICC lines are not considered minor procedures)
- No other current anti-cancer agents
- No concurrent nonsteroidal anti-inflammatory medications known to inhibit platelet function or known to selectively inhibit cyclooxygenase activity
- No concurrent enzyme inducing anticonvulsants
- No concurrent HDAC inhibitors (e.g., valproic acid)
- No concurrent anticoagulants including systemic thrombolytic agents, heparin, low molecular weight heparins, or warfarin except as required to maintain patency of pre-existing permanent vascular catheters or for prevention of thrombosis in the post-operative period
Exclusion
Key Trial Info
Start Date :
January 26 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT01236560
Start Date
January 26 2011
End Date
December 31 2023
Last Update
February 20 2024
Active Locations (132)
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1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
3
Kaiser Permanente Downey Medical Center
Downey, California, United States, 90242
4
Loma Linda University Medical Center
Loma Linda, California, United States, 92354