Phase II Study to Evaluate the Efficacy and Safety of Intravenous Palonosetron in Primary Glioma Patients Receiving Standard Radiotherapy and Concomitant Temozolomide
We will conduct a phase II single arm trial of Palonosetron (PALO) for the prevention of
RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant
temozolomide (TMZ). All eligible patients should receive a planned total dose of 54-60 GY
of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For
each week of radiation patients will receive a single 0.25 mg intravenous dose of
palonosetron approximately 30 minutes before each week of radiation fraction. This schedule
will be repeated for each week of radiation for a total of 6 weeks. After the start of
radiation the type of rescue medication will be up to the investigator's discretion (however
given the results of recent published phase II study by Navari et. al. we recommend using
olanzepine for rescue medication). All patients will be given written informed consent.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
To determine the safety and tolerability of intravenous palonosetron in the prevention of radiation induced nausea and vomiting (RINV) in primary glioma patients receiving radiation (RT) and concomitant temozolomide (TMZ)
6 weeks
Yes
Mary Lou Affronti, RN, MSN, ANP
Principal Investigator
Duke University Health System
United States: Food and Drug Administration
Pro00015573
NCT00900757
August 2009
December 2012
Name | Location |
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The Preston Robert Tisch Brain Tumor Center at Duke | Durham, North Carolina 27710 |