A phase II trial with cetuximab, bevacizumab and irinotecan for patients with malignant glioblastomas and progression after radiation therapy and temozolamid - CBI-GBM
- Conditions
- Recurrent or progressive primary GBM in patients with performance status (PS) 0-2.
- Registration Number
- EUCTR2006-000182-10-DK
- Lead Sponsor
- Rigshospitalet, Finsen Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 32
Written informed consent.
Histological verification of primary GBM.
Recurrence or progression after standard treatment (debulking surgery of possible, radiotherapy and temozolamide within last six months).
Evidence of measurable recurrent progressive primary GBM (CT/MRI scan).
An interval of at least 6 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 18-60.
Life expectancy > 3 month.
Normal organ function.
Fertile females must use oral contraceptive, IUD (intrauterine device) or preservatives. Fertile males must use preservatives.
No evidence of haemorrhage on baseline (CT/MRI scan).
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
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.
No hypercholesterolemia or hypertriglyceridemia (despite lipid-lowering therapy).
Any significant cardiac disease (New York Heart Association Class II or greater), arytmia, congestive heart failure, acute myocardial infaction 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 .
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
- Primary Outcome Measures
Name Time Method Main Objective: Determine the progression free survival (PFS), response rate (RR) of the combination of cetuximab, bevacizumab and irinotecan (CBI) in patients with recurrent GBM.;Secondary Objective: Determine safety, tolerability and toxicity in patients with recurrent or progressive GBM. <br>Determine overall survival (OS).<br>Correlate tumor response with the expression of tumor markers (EFGR, p-EGFR, EGFRvIII, VEGF, PTEN, Akt, p-Akt, mTOR, p-mTOR, p53)<br>;Primary end point(s): Progression free survival (PFS), response rate (RR) of the combination of cetuximab, bevacizumab and irinotecan (CBI) in patients with recurrent GBM).<br>Response will be measured using the MacDonald response criteria.<br>All Adverse Events must be recorded on the adverse event section of the CRF and graded for intensity using NCI-CTC (v3.0)
- Secondary Outcome Measures
Name Time Method