The Preston Robert Tisch Brain Tumor Center at Duke

Clinical Trials for Adults   | Phase II Study to Evaluate the Efficacy and Safety of Intravenous Palonosetron in Primary Glioma Patients receiving Standard Radiotherapy and Concomitant Temozolomide

Primary Objective
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)

Secondary Objectives

  • To determine the efficacy of palonosetron in primary glioma patients receiving six weeks of RT and concomitant TMZ
  • To evaluate the effect s of palonosetron on the quality of life of primary glioma patients receiving six weeks of RT and Concomitant TMZ.

Patient Eligibility

  • Karnofsky ≥ 60%
  • 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.
  • Patient must not have had previous participation in any clinical trial involving palonosetron.
  • Patient must not have had prior and concomitant cancer chemotherapy and radiotherapy

Study Design and Treatment:
This is a a phase II single arm trial of Palonosetron (PALO) for the prevention of RINV (Radiation Induced Nausea and Vomiting) 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.

Patients will be completing Common Toxicity Criterion (CTC version 3.0) Grading Assessment Tool and the Osoba nausea and vomiting questionnaire on day 1, 3 and 6 of each week of radiation therapy. In addition they will be recording the use of rescue medication.


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