A phase II trial with bevacizumab and irinotecan for patients withprimary brain tumors and progression after standard therapy - BI-Brain-01

Phase 1

• Conditions: Primary malignant brain tumors

• Registration Number: EUCTR2006-006011-74-DK
• Lead Sponsor: Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-20
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

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

Inclusion Criteria

·Written informed consent
·Histological verification of primary malignant brain tumor, or grade II glioma, meningeoma or ependymoma with progression and no other treatment options (including brain stem gliomas without histological verification)
·Recurrence or progression after standard treatment (debulking surgery of possible, radiotherapy and temozolamide or other chemotherapy within last six months)
·Evidence of measurable recurrent progressive disease (CT/MRI scan)
·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.
·PS 0-2 (ECOG scale)
·Age > 18
·Life expectancy > 3 month
·Normal organ function:
- Platelets > 125 x 109/l
- Hemoglobin >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 clearance > 45 ml/min
- APTT < normal limit
- INR < normal limit
·Fertile females must use oral contraceptive, IUD (intrauterine device) or preservatives. Fertile males must use preservatives.

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

·Radiotherapy or chemotherapy within the last 4 weeks.
·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 other active malignancy or previous malignancies within the last 5 years, except, adequately treated basal or squamous cell carcinoma of the skin, or carcinoma in situ.
·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, coagulapathy or taking ASA, NSAIDs or clopidogrel
·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
·Blood pressure > 150/100 mmHG
·Grade 2 or greater proteinuria

Study & Design

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