MRI-perfusion and FLT- and FET-PET during bevacizumab monotherapy for patients with recurrent Glioblastoma Multiforme

• Conditions: Recurrent Glioblastoma multiforme; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-001049-42-DK
• Lead Sponsor: Department of Oncology, Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-12
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 < 3 x upper normal limit
•Bilirubin < 1,5 x upper normal limit
•Creatinine within normal limits
•APTT < normal limit
•INR < normal limit
•Fertile females must use oral contraceptive, IUD (intrauterine device), gestagen sustained release injection, subdermal implantation, transdermal patch or hormonal vaginal ring. This must continue at least three months after the patients is off-study. Fertile males must use preservatives
•No sign of cerebral bleeding
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

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 < 325 mg daily and clopidogrel)
•Blood pressure > 150/100 mm Hg
•Grade 2 or greater proteinuria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified