high grade glioma MedDRA version: 9.1 Level: LLT Classification code 10065443 Term: Malignant glioma
Conditions
Interventions
Trade Name: AVASTIN
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Bevacizumab
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 10-
Tra
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histopathologic diagnosis of high grade glioma 2. Evidence of recurrent or refractory high grage glioma after at least 1 conventional first line treatment 3. Measurable disease by MRI 4. Age > 14 years 5. Karnofsky Performance Score ≥ 60% 6. Life expectancy ≥ 3 months 7. Intracranial surgery performed al least 6 weeks prior to entry 8. No anticancer therapy (chemotherapy or radiotherapy) for at least 4 weeks (6 weeks for nitrosureas) prior to entry 9. Haematology: a. Neutrophils ≥ 1.5 x 109/l b. Platelets ≥ 125 x 109/l c. Hematocrit > 29% 10. Renal function: creatinina ≤1.5 mg/dL 11. Liver function a. Bilirubin ≤ 1.5 mg/dL b. AST/ALT =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of any other malignancy within 5 years (except non melanoma skin cancer or carcinoma in situ of the cervix) 2. Other concomitant anticancer treatment 3. Pregnant or nursing females 4. Hemorrhage on baseline MRI of the brain 5. Previous treatment with Bevacizumab 6. Clinically significant cardiovascular diseases: History of myocardial infarction within 6 months prior to study registration New York Heart Association (NYHA) Grade II or greater heart failure Serious cardiac arrhythmia requiring medication Blood pressure of  150/100 mmHg in patient under treatment Unstable angina Clinically significant peripheral vascular disease 7. History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 6 months prior to study registration 8. Active inflammatory bowel disease or diverticulitis 9. History of intracerebral abscess within 6 months prior to study registration 10. Major surgical procedure, open biopsy, or significant traumatic injury within 14 days prior to study registration 11. Minor surgical procedures, stereotactic biopsy, fine needle aspirations or core biopsies within 7 days prior to registration 12. Serious non healing wound, active infection, ulcer, or bone fracture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the rate of objective confirmed tumor response of bevacizumab in combination with irinotecan in patients with recurrent or refractory high grade glioma after conventional treatment;Secondary Objective: To determine the overall survival, the time from the date of first treatment to death To determine the duration of objective confirmed tumor response, defined as the time from first documentation of objective response to the first objective or clinical documentation of progression. To determine time to tumor progression, the time from the date of first treatment to the date of first objective or clinical documentation of tumor progression or death due to any cause. To assess the safety and tolerability of the combination of bevacizumab and irinotecan;Primary end point(s): The primary efficacy endpoint is defined as the rate of objective confirmed tumor response of bevacizumab in combination with irinotecan in patients with recurrent or refractory high grade glioma after conventional treatment. | — |
Countries
Italy
Outcome results
None listed