Avastin / Irinotecan in Patients With Recurrent or Progressive Malignant Glioma

Inclusion Criteria

• •1. Patients present with a first or second tumor recurrence / progression of a histological confirmed supratentorial malignant glioma WHO Grade III-IV (Classification following WHO criteria).
• •* Patients must have recovered from the effects of surgery
• •* To adequately asses the malignant glioma before surgery and the extent of residual disease postoperatively, two MRIs scans have to be performed:
• •* A first standard MRI scan has to be done within 1 week before surgery to document a progressed or recurrent malignant glioma.
• •* A second standard / functional MRI scan has to be done between 24 and 48 hours after surgery to document the postoperative malignant glioma (Baseline MRI scan).
• •* FET- / FLT-PET scans have to be done within 2 weeks after surgery to document the postoperative malignant glioma (Baseline PET scans).
• •Patients without surgical resection of the tumor recurrence / progression: Patients must have evidence of tumor progression measured by standard MRI sequences (MacDonald criteria).
• •* Additional functional MRI sequences have to be done within 1 week prior to study enrollment.
• •* FET- / FLT-PET scans have to be done within 2 weeks after surgery to document the postoperative malignant glioma (Baseline PET scans).
• •3. Resolution of all acute toxic effects of prior therapy to grade ≤ 1 (except alopecia)
• •4. Patients must have an ECOG performance status of 0-2
• •5. Patients must be ≥ 18 years and ≤ 80 years of age, with a life expectancy of greater than 8 weeks
• •6. Patients must have adequate organ function as defined by the following criteria:
• •Bone Marrow Reserve
• •* Platelets ≥ 75.000/μL
• •* Absolute Neutrophil Count ≥ 1500/μL
• •* Hemoglobin ≥ 10.0 g/dL Blood Coagulation
• •* aPTT ≤ 1.5 times upper limit of normal (ULN) Hepatic Function
• •* ASAT and ALAT ≤ 2.5 times ULN
• •* ALP ≤ 2.5 times ULN
• •* Total SERUM Bilirubin \< 1.5 times ULN Renal Function
• •* SERUM Creatinine ≤ 1.5 times ULN Metabolism
• •* SERUM Albumin ≥ 3.0 g/dL All tests must be performed ≤ 3 days prior to study enrollment. Eligibility for hemoglobin count may be reached by transfusion.
• •7. Signed and dated informed consent document by the patient, indicating that the patient has been informed of all the pertinent aspects of the trial prior to study enrollment.
• •8. Willingness and ability of the patient to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.