Avastin and Temozolomide attacking Relapsed Glioma

Completed

Conditions: gliomabevacizumabtemozolomidePFS6

Registration Number: NL-OMON26843

Lead Sponsor: Prof.dr. D.J. Richel

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion 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).

Exclusion Criteria

1. Patients with inability to comply with protocol or study procedures (for example, an inability to swallow tablets).

2. 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main study parameters/endpoints: The progression free survival at 6 months (PFS6) is the main study parameter. This is about 9% in this patient group under the old treatment regimen. We expect a PFS6 of about 30% with the combination of bevacizumab and temozolomide. Therapy regimen will continue after 6 months.

Secondary Outcome Measures

Name	Time	Method
1. Safety<br /><br>2. Overall survival<br /><br>3. Response rate<br /><br>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.<br /><br>5. Levels of Circulating Endothelial Cells (CECs), <br /><br>6. Circulating Progenitor Cells (CPCs), <br /><br>7. Vascular endothelial growth factor (VEGF)<br /><br> 8. Placental growth factor (PlGF) in peripheral blood will be determined at different time points.