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Phase II Study to Evaluate the Efficacy and Safety of Intravenous Palonosetron in Primary Glioma Patients Receiving Standard Radiotherapy and Concomitant Temozolomide

Phase 2
18 Years
90 Years
Not Enrolling
Malignant Glioma

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Trial Information

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.

Inclusion Criteria:

- Age ≥ 18 years;

- Karnofsky ≥ 60%;

- Hematocrit > 29%, ANC > 1,000 cells/*1, platelets > 100,000 cells/*I;

- Serum creatinine < 1.4 mg/dl; serum SGOT and bilirubin < 1.5 times upper limit of

- 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

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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)

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

Mary Lou Affronti, RN, MSN, ANP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Health System


United States: Food and Drug Administration

Study ID:




Start Date:

August 2009

Completion Date:

December 2012

Related Keywords:

  • Malignant Glioma
  • Primary Glioma
  • Palonosetron
  • Standard Radiotherapy
  • Temozolomide
  • Glioma



The Preston Robert Tisch Brain Tumor Center at Duke Durham, North Carolina  27710