Treatment with bevacizumab and irinotecan in patients with recurrent or refractory high grade glioma after conventional treatment. - ND

• Conditions: high grade glioma; MedDRA version: 9.1Level: LLTClassification code 10065443Term: Malignant glioma

• Registration Number: EUCTR2009-012582-64-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-27
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

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

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 < 1.5 x normal upper limit
12.Activated partial thromboplastin time (aPTT) < 1.5 &#61620; normal upper limit in the absence of treatment with anticoagulation medications
13.Contrast enhanced cranial MRI must have been performed within 3 weeks of study entry
14.Dose of corticosteroid stable for at least 7 days before treatment initiation
15.The pregnancy will not have to be started during treatment and for following 90 days
16.Signed, informed consent
Are the trial subjects under 18? yes
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

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 &#61502; 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

Study & Design

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