Patients with a recurrent high grade glioma (after primary treatment) MedDRA version: 9.1 Level: LLT Classification code 10018338 Term: Glioma
Conditions
Interventions
Trade Name: Bevacizumab
Pharmaceutical Form: Intravenous infusion
Trade Name: Temozolomide
Pharmaceutical Form: Tablet
Trade Name: Oradexon
Pharmaceutical Form: Tablet
Pharmaceutical form of the pla
Sponsors
Academic Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible to be included in the study if they meet all of the following criteria: 1. Patients present with histologically confirmed diagnosis of intracranial recurrent high grade glial tumor (WHO grade IV). Patients may be entered based on local pathology from the original tumor specimen. 2. Patients must have evidence of tumor progression following radiation and chemotherapy as measured by MRI (MRI-0 at presentation). 3. Patients may have received up to two prior chemotherapy regimens (with concurrent radiotherapy). 4. Patients may have undergone prior surgical resection and will be eligible if recovered from the effects of surgery. 5. Patients must have adequate organ function, including the following: a. Adequate bone marrow reserve: Absolute neutrophil count (ANC) > 1.5 x 109/L, platelet count > 100 x 109/L, and hemoglobin > g/dL (6.21 mmol/L). b. Hepatic: total bilirubin 70%. 7. Patients must be > 18 years of age, with a life expectancy of greater than 8 weeks. 8. Patient compliance and geographic proximity that allow for adequate follow up is required. 9. Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after discontinuation of study treatment. Women with childbearing potential must have a negative serum pregnancy test =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria: 11. Patients with inability to comply with protocol or study procedures (for example, an inability to swallow tablets). 12. Patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. 13. Patients receiving EIAEDs (Enzyme-inducing antiepileptic drugs). Patients must discontinue EIAEDs > 14 days prior to study enrollment. The investigator may prescribe non-EIAEDs. 14. Patients receiving any other anticancer therapy, any anticoagulant therapy. 15. Patients with serious concomitant systemic disorders (for example, active infection or abnormal Electrocardiogram indicative of cardiac disease) that, in opinion of the investigator, would compromise the safety of the patient and his/her ability to complete the study. 16. Patients with prior thrombo-embolic events.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Six month progression free survival (PFS6) in patients with recurrent high grade gliomas treated with bevacizumab and metronomic dose temozolomide, compared to historical controls (PFS6 = 10%).;Secondary Objective: 1. Safety 2. Overall survival 3. Response rate 4. Changes in tumor blood flow and vascular permeability (Ktrans and rCBV values) during the first 20 days of treatment with bevacizumab in comparison with dexamethasone and the combination bevacizumab + dexamethasone. 5. Biomarkers in periferal blood;Primary end point(s): Six month progression free survival in patients with recurrent high grade gliomas treated with bevacizumab and metronomic dose temozolomide, compared to historical controls (PFS6 = 10%). | — |
Countries
Netherlands
Outcome results
None listed