Conditions: Brain Cancer
Keywords: Aloxi Brain Neoplasm, Primary Brain Neoplasms, Malignant
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 63
Healthy volunteers: no

Brief summary:
1. Primary Objective:

   * To determine the efficacy and tolerability of palonosetron and dexamethasone in preventing acute CINV in brain tumor patients during the first 24 hours of receiving Irinotecan /Bevacizumab regimens.
2. Secondary Objective

   * To determine the safety and tolerability of palonosetron in brain tumor patients.
   * To determine the effects of glucocorticoid and anticonvulsants on the efficacy of palonosetron.
   * To determine the efficacy of palonosetron and dexamethasone in preventing delayed CINV in brain tumor patients during days 2-5.
   * To determine if patients receiving palonosetron have less fatigue than baseline.

Detailed description:
Before the patients receive the palonosetron, a physical exam and blood tests are performed to determine eligibility. If eligible and willing, subjects are given Palonosetron intravenously. Subjects are given the Palonosetron and Dexamethasone 30 minutes before the first dose of Irinotecan and Bevacizumab chemotherapy. The total expected duration of participation is 57 days. Subjects are also asked to complete 4 questionnaires about nausea and vomiting, as well as daily functioning and fatigue. Subjects are asked to complete these questionnaires before starting chemotherapy, the day of starting chemotherapy and for the next 4 days after receiving chemotherapy, for a total of 6 times. Subjects are asked to complete this set of questionnaires each of the 3 times that they receive chemotherapy during the 6-week treatment cycle.

The other treatments subjects would normally receive for their brain tumor and their routine care are not affected by the study.

Arms:
arm 1: Patient receives IV Aloxi

Interventions: intervention 1: Palonosetron (Aloxi) and Dexamethasone
Intervention descriptions: intervention 1: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy.

Protocol document: