Study of Intraparenchymal Therapy as Adjunct Therapy in Patients With Recurrent, Resectable Glioblastoma Multiforme.

Exclusion Criteria

• •1. patient must not be enrolled in any other clinical trial for 30 days before or after participation in this trial
• •2. history of allergic reactions attributed to compounds of similar chemical make-up or composition to CM-BC2, alginate or irinotecan; or has any other contraindications to irinotecan therapy
• •3. open communication between the ventricle CSF (cerebrospinal fluid) and tumour resection cavity/site must be avoided. In the case of opening ventricles during surgery, the surgeon must decide whether effective closure is possible by obstructing the gap with Gelfoam/other appropriate materials
• •4. Tumor surgery, other than stereotactic biopsy of the GBM, or other neurosurgery within 30 days prior to study entry
• •5. Multiple GBM lesions
• •6. Irinotecan chemotherapy within 30 days prior to study treatment
• •7. radiotherapy or stereotactic (gamma knife) radiosurgery within 90 days prior to study entry
• •8. loco-regional (intra-cranial) therapy for the treatment of GBM, including administration of biodegradable polymer wafers containing Carmustine and/or brachytherapy, in the 6 months prior to study entry
• •9. Significant liver function impairment: aminotransferase (AST) or alanine transaminase (ALT) greater than 2.5 x the upper limit of normal (ULN), or total bilirubin greater than 2 x ULN
• •10. significant renal impairment: creatinine greater than 2.0 mg/dL
• •11. Coagulopathy Prothrombin time (PT) or partial thromboplastin time (APTT) of less than 1.5 x control, and/or platelet count of less than 100 x 10⁹/L
• •12. Hb less than 8 g/dL and/or neutrophil count (ANC - Absolute Neutrophil Count) of less than 1 x 10⁹/L
• •13. Any condition that, in the investigator's opinion, makes it in the patient's best interest not to participate in the study
• •14. Pre-existing cerebral oedema that, in the surgeon's opinion, poses unacceptable risk of post-operative oedema. This decision may be at time of surgery.
• •15. Presence of concurrent malignancy, except for adequately controlled limited basal cell carcinoma of the skin or carcinoma in situ of the cervix