Intravenous Palonosetron With Radiotherapy and Concomitant Temozolomide
Condition: Malignant Glioma
MeSH terms: Glioma
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      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 olanzapine
      for rescue medication). All patients will be given written informed consent.
    

Intervention name(s): Palonosetron (PALO)
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): Aloxi
Intervention MeSH terms: Palonosetron
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Primary Glioma; Palonosetron; Standard Radiotherapy; Temozolomide