A randomized phase II trial with bevacizumab, irinotecan and cerebral radiotherapy versus bevacizumab, temozolomide and cerebral radiotherapy as first line treatment for patients with glioblastoma multiforme

Phase 1

• Conditions: This study investigates first line experimental non-surgical therapy in patients with glioblastoma multiforme in good performance status; MedDRA version: 9.1Level: LLTClassification code 10018337Term: Glioblastoma multiforme

• Registration Number: EUCTR2008-001144-39-DK
• Lead Sponsor: Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-04-28
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

·Signed informed consent
·Histological verified primary glioblastoma multiforme
·No prior therapy for GBM, except for primary surgical resection or biopsy
·PS 0-2
·Age > 18
·Expected survival > 3 months
·Adequate liver, renal and bone-marrow function, determined as:
oThrombocytes > 100 x 109/liter
oHemoglobin >6.2 mmol/liter
oLeukocytes > 3 x 109/liter
oNeutrophil granulocytes > 1.5 x 109/liter
oASAT and/or ALAT < 3 x upper normal limit
oBilirubin < 1.5 x upper normal limit
oSerum-creatinin < upper normal limit or glomerular filtration rate >60 ml/min (corrected for age) determined by measurement of clearance of Cr-EDTA
oAPTT < upper normal limit
oINR < upper normal limit
·Fertile women of childbearing age must use proper anti-conception (oral contraceptives, IUD and/or condom). Fertile men must use condom
·No sign of cerebral bleeding on cerebral MR-scanning at baseline
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·Previous therapy of GBM, including radiotherapy and the use of biological targeted” drug, e.g. drugs targeted against the VEGF- or EGFR pathway
·Concurrent use of medication that can affect the interpretation of the results from the study, e.g. use of immunosuppressive drugs, except corticosteroids
·Conditions (medical, social or physical) that may compromise proper information and/or follow-up
·Other concurrent or previous cancer within 5 years, except adequately treated basal or planocellular skin cancer, or cervical carcinoma in situ
·Significant heart disease (according to the New York Heart Association class II or more severe), clinically significant arrhythmia or unstable angina pectoris/acute myocardial infarction within last 6 months
·Clinical significant peripheral arterial disease
·Known or suspected disorders of coagulation or concurrent therapy with ASA, NSAID or clopidogrel
·Major surgery, open biopsy or greater trauma, or expectations thereof, within 28 days prior to start of therapy
·Minor surgery or needle biopsy, or expectations thereof, within 7 days prior to start of therapy
·Known or suspected abdominal fistulas, gastrointestinal perforations or intra-abdominal abscesses within 6 months prior to start of therapy
·Known or active HIV or Hepatitis B/C infection
·Concurrent ongoing significant infection or diabetes mellitus not adequately controlled medically
·Clinically significant non-healing ulcers
·Active ventricular or duodenal ulcers within 6 months prior to start of therapy
·Recent bone-fracture (<3 months)
·Pregnancy or lactation
·Need for systemic anticoagulant therapy at time of start of therapy
·Blood pressure > 150/100 mmHg (patients are allowed to receive proper antihypertensive medication)
·Proteinuria = 1 gram/day
·Known allergy towards irinotecan (or related substance) or vehicle
·Known allergy towards temozolomide (or related substance) or vehicle
·Known allergy towards bevacizumab (or related substance) or vehicle

Study & Design

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