This study investigates first line experimental non-surgical therapy in patients with glioblastoma multiforme in good performance status MedDRA version: 9.1 Level: LLT Classification code 10018337 Term: Glioblastoma multiforme
Conditions
Interventions
Trade Name: Avastin
Product Name: Avastin
Product Code: bevacizumab
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: Temodal
Product Name: Temodal
Product Code: Temozolomid
Phar
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
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: o Thrombocytes > 100 x 109/liter o Hemoglobin >6.2 mmol/liter o Leukocytes > 3 x 109/liter o Neutrophil granulocytes > 1.5 x 109/liter o ASAT and/or ALAT 60 ml/min (corrected for age) determined by measurement of clearance of Cr-EDTA o APTT =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 ( 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy and feasibility of two different chemotherapy regimens alone and when combined with cerebral radiotherapy as first line therapy in patients with newly diagnosed GBM following primary surgery.;Secondary Objective: To determine safety of each of these chemotherapy regimens alone and in combination with cerebral radiotherapy.;Primary end point(s): The primary endpoint is to determine the response rate. Response is evaluated after 2 cycles of systemic therapy alone, 2 months after completed radiotherapy, and hereafter after every 2nd treatment cycle as long as therapy is continued. | — |
Countries
Denmark
Outcome results
None listed