Brain Cancer Clinical Trial
Official title:
A Phase II Single Arm Trial of Palonosetron (PALO) for the Prevention of Acute and Delayed Chemotherapy Induced Nausea and Vomiting (CINV) in Malignant Glioma (MG) Patients Receiving Irinotecan in Combination With Bevacizumab
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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