Aloxi for Prevention of Chemotherapy Induced Nausea and Vomiting in Malignant Glioma Patients Receiving Irinotecan With Bevacizumab

Exclusion Criteria

• •Patients are excluded from this study if they meet any of the following criteria:
• •Inability or unwillingness to understand or cooperate with study procedures.
• •Received any intravenous drug with potential anti-emetic effect within 24 hours prior to the start of study-designated chemotherapeutic agent or be scheduled to receive any drug of this type (with the exception of administration of the palonosetron/dexamethasone infusion solution) at any time during the trial, including the following:
• •5 HT3 receptor antagonists;
• •Dopamine receptor antagonists (metoclopramide);
• •Phenothiazine anti-emetics (prochlorperazine, thiethylperazine and perphenazine);
• •Diphenhydramine, scopolamine, chlorpheniramine maleate, trimethobenzamide. Diphenhydramine will be allowed if given for prophylactic treatment of hypersensitivity reactions associated with the administration of taxanes;
• •Haloperidol, droperidol, tetrahydrocannabinol, or nabilone; and
• •Any systemic corticosteroid (hydrocortisone, methylprednisolone, prednisone). Topical or inhaled preparations are allowed;
• •Previous participation in any clinical trial involving palonosetron (RS-25259 of Syntex).
• •Any vomiting, retching or NCI Common Toxicity Criteria version 3.0 grade 2-4 nausea (see Appendix 8.6) in the 24 hours preceding chemotherapy.
• •Ongoing vomiting from any organic etiology.
• •Will receive radiotherapy of upper abdomen or cranium within one week prior to or during the study.
• •Received palonosetron within 14 days prior to study enrollment (AloxiTM).
• •Evidence of central nervous system (CNS) hemorrhage on baseline MRI on CT scan.
• •Co -medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids.
• •Prophylactic medication for the prevention of nausea and vomiting 24 hours prior to the start of chemotherapy through 120 hours after the initiation of chemotherapy on Study Day 1 (Study Day 6) is prohibited, with the exception of the study drug. Corticosteroids will be allowed for treatment of cerebral swelling. Diphenhydramine will be allowed only if given for prophylactic treatment of hypersensitivity reactions associated with the administration of taxanes, as per the package insert for these agents. Rescue medication for treatment of nausea and vomiting is permitted after chemotherapy at the discretion of the investigator. The agent, dose, and time of administration will be recorded in the patient diary.