Primary malignant brain tumors
Conditions
Interventions
Trade Name: Campto
Product Name: Campto
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: Avastin
Product Name: Avastin
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
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 45 ml/min - APTT =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the disease control rate (progression free survival (PFS), response rate (RR) of the combination bevacizumab and irinotecan (BI) in patients with recurrent primary brain tumors.;Secondary Objective: Determine safety, tolerability and toxicity in patients with recurrent or progressive primary brain tumors Determine overall survival (OS). Correlate tumor response with the expression of plasma tumor markers and PET results of metabolism and blood flow. ;Primary end point(s): This is an investigator-initiated, open label phase II study, where patient with recurrent primary brain tumors will be considered for the study. The patient population will include a total of evaluable 54 patients. The expected rate of accrual is 3-6 patients a month. The estimated study start date is October 2006, with the last patient enrolled in April 2008. With additional follow up, the clinical part of the study will be completed in April 2010. The patients will be followed according to the Schedule of Study Events (Appendix 3). All patients will be followed until disease progression or death is documented or a follow-up of 2 years is reached. During this follow-up period tumor response measurements will be carried at Rigshospitalet. If the patient goes off study for any reason other than PD, they still will be evaluated every 3 months for survival. | — |
Countries
Denmark
Outcome results
None listed