Recurrent Glioblastoma multiforme
Conditions
Interventions
Sponsors
Department of Oncology, Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent • Histological verification of glioblastoma multiforme with progression after temozolomid and radiotherapy • Evidence of measurable recurrent progressive disease (MRI scan) • Clinical (RANO/MacDonald criteria) or CT/MRI scan verified progression • An interval of at least 4 weeks between prior surgical resection and study enrolment • An interval of at least 4 weeks between prior radiotherapy or chemotherapy and enrolment on this protocol. • WHO performance status 0-1 • Age > 18 • Life expectancy > 3 month • Normal organ function: • Platelets > 125 x 109/l • Haemoglobin > 6,2 mmol/l • Leukocytes > 3 x 109/l • ACN> 1,5 x 109/l • ASAT or ALAT =65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: • Radiotherapy or chemotherapy within the last 4 weeks. • Prior treatment with bevacizumab or another VEGF inhibitor • Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids • Any condition (medical, social, psychological), which would prevent adequate information and follow-up • Any significant cardiac disease (New York Heart Association Class II or greater), arytmia, congestive heart failure, acute myocardial infarction within 6 months or unstable angina pectoris. • Clinically significant peripheral vascular disease • Evidence of bleeding diathesis or coagulapathy • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 0, anticipation of need for major surgical procedure during the curse of the study • Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to day 0 • History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 month prior to day 0 • History of known HIV, Hepatitis B and Hepatitis C negative • Any ongoing infection, uncontrolled diabetes mellitus, serious non-healing wound, ulcer or bone fracture • Pregnancy or breast feeding • Requires therapeutic anti-coagulation (except LMWH or heparin flushing of central venous catheters) or anti-thrombotic therapy (except acetyl salicylic acid 150/100 mm Hg • Grade 2 or greater proteinuria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine changes in tumor perfusion parameters defined by perfusion MRI and changes in tumor proliferation defined by FLT- and FET-PET;Secondary Objective: • Determine changes in tumor and blood biomarkers of angiogenesis, hypoxia and proliferation • Determine changes in tumor and blood biomarkers of angiogenesis, hypoxia and proliferation and correlate these with clinical outcome. ;Primary end point(s): Changes in tumor perfusion parameters defined by perfusion MRI and changes in tumor proliferation defined by FLT- and FET-PET and correlate these with the clinical outcome;Timepoint(s) of evaluation of this end point: At baseline and within the first two weeks after administartion of study drug | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes in tumor and blood biomarkers of angiogenesis, hypoxia and proliferation and changes in tumor and blood biomarkers of angiogenesis, hypoxia and proliferation and correlate these with clinical outcome. ;Timepoint(s) of evaluation of this end point: At baseline and within the first two weeks after administartion of study drug | — |
Countries
Denmark
Outcome results
None listed