Intravenous Palonosetron With Radiotherapy and Concomitant Temozolomide
Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
1. Purpose and objective:
1. To determine the safety and tolerability of palonosetron in the prevention of radiation
induced nausea and vomiting (RINV) in primary glioma patients receiving radiation (RT)
and concomitant temozolomide (TMZ).
2. To determine the efficacy of palonosetron in primary glioma patients receiving six weeks
of RT and concomitant TMZ
3. To evaluate the effect s of palonosetron on the quality of life of primary glioma
patients receiving six weeks of RT and Concomitant TMZ.
2. Study activities and Population group: 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 30 minutes before each week of radiation fraction.
This schedule will be repeated for each week of radiation for a total of 6 weeks. Forty
subjects with gliomas will participate.
3. Data analysis and risk/safety issues: The frequency of toxicity will be summarized by type
and the most severe grade experienced. The complete response rate, defined as the proportion
of patients with no emetic episode or use of rescue medication while receiving radiation and
concomitant temozolomide, will be estimated with a 95% confidence interval.
Phase:
Phase 2
Details
Lead Sponsor:
Duke University
Collaborators:
Eisai Inc. National Institute of Neurological Disorders and Stroke (NINDS)