Intravenous Palonosetron With Radiotherapy and Concomitant Temozolomide

Inclusion Criteria:

• Age ≥ 18 years;
• Karnofsky ≥ 60%;
• Hematocrit > 29%, ANC > 1,000 cells/*1, platelets > 100,000 cells/*I;
• Serum creatinine < 1.4 mg/dl; serum SGOT and bilirubin < 1.5 times upper limit of normal;
• For patients on corticosteroids, they must have been on a stable dose for 1 week prior to entry, and the dose should not be escalated over entry dose level, if clinically possible;
• Signed informed consent approved by the Institutional Review Board prior to patient entry;
• If sexually active, patients w8ill take contraceptive measures for the duration of the treatments.

Exclusion Criteria:

• Pregnancy or breastfeeding;
• Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids;
• Inability or unwillingness to cooperate with the study procedures;
• Prophylactic medication for the prevention of nausea and vomiting 24 hours prior to the start of radiation therapy through the full course of radiation therapy is prohibited, with the exception of the study drug. Corticosteroids will be allowed for treatment of cerebral swelling. Rescue medication for treatment of nausea and vomiting is permitted after radiation therapy at the discretion of the investigator. The agent, dose, and time of administration will be recorded in the patient diary;
• Previous participation in any clinical trial involving palonosetron;
• Any vomiting, retching, or NCI Common Toxicity Criteria version 3.0 grade 2-4 nausea in the 24 hours preceding radiation and chemotherapy;
• Ongoing vomiting from any organic etiology;
• Will receive radiotherapy of upper abdomen within one week prior to or during the study;
• Received palonosetron within 14 days prior to study enrollment;
• Prior and Concomitant Medications for Prevention/Treatment of Nausea and Vomiting;
• Prior and Concomitant Cancer Chemotherapy and Radiotherapy.