Intravenous Palonosetron With Radiotherapy and Concomitant Temozolomide
Condition: Malignant Glioma
MeSH terms: Glioma
Intervention: Palonosetron (PALO)
Intervention description: 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.
Intervention MeSH terms: Palonosetron
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Primary Glioma; Palonosetron; Standard Radiotherapy; Temozolomide

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years;

          -  Karnofsky ≥ 60%;

          -  Hematocrit > 29%, absolute neutrophil count (ANC) > 1,000 cells/*1, platelets >
             100,000 cells/*I;

          -  Serum creatinine < 1.4 mg/dl; serum glutamate oxaloacetate transaminase (SGOT) and
             bilirubin < 1.5 times upper limit of normal;

          -  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;

          -  Signed informed consent approved by the Institutional Review Board prior to patient
             entry;

          -  If sexually active, patients w8ill take contraceptive measures for the duration of the
             treatments.

        Exclusion Criteria:

          -  Pregnancy or breastfeeding;

          -  Co-medication that may interfere with study results; e.g. immuno-suppressive agents
             other than corticosteroids;

          -  Inability or unwillingness to cooperate with the study procedures;

          -  Prophylactic medication for the prevention of nausea and vomiting 24 hours prior to
             the start of radiation therapy through the full course of radiation therapy is
             prohibited, with the exception of the study drug. Corticosteroids will be allowed for
             treatment of cerebral swelling. Rescue medication for treatment of nausea and vomiting
             is permitted after radiation therapy at the discretion of the investigator. The agent,
             dose, and time of administration will be recorded in the patient diary;

          -  Previous participation in any clinical trial involving palonosetron;

          -  Any vomiting, retching, or NCI Common Toxicity Criteria version 3.0 grade 2-4 nausea
             in the 24 hours preceding radiation and chemotherapy;

          -  Ongoing vomiting from any organic etiology;

          -  Will receive radiotherapy of upper abdomen within one week prior to or during the
             study;

          -  Received palonosetron within 14 days prior to study enrollment;

          -  Prior and Concomitant Medications for Prevention/Treatment of Nausea and Vomiting;

          -  Prior and Concomitant Cancer Chemotherapy and Radiotherapy.