Patient Satisfaction, Efficacy and Compliance of Antiemetic Patch vs Pill in Malignant Glioma Patients

The primary objective of this study is to assess whether malignant glioma patients receiving
radiation therapy and concomitant TMZ are more satisfied with ondansetron or granisetron
patch for the prevention of nausea and vomiting. The secondary objectives are 1) to compare
the efficacy and compliance of granisetron patch and ondansetron in the prevention of nausea
and vomiting during the 6 weeks of RT and concomitant TMZ, and 2) to assess the safety of
the granisetron patch in preventing radiation induced nausea and vomiting in primary glioma
patients receiving RT and TMZ.

All eligible subjects should receive a planned total dose of 54-60 GY of radiation and 75
mg/m2 of temozolomide daily for a total of six weeks. Subjects will be randomized to receive
one of two treatment sequences of antiemetic therapy for the prevention of nausea and
vomiting associated with RT and concomitant TMZ. Sequence #1 involves administration of
ondansetron for 3 weeks followed by the use of granisetron patch for 3 weeks; whereas
sequence #2 involves the use of the granisetron patch for 3 weeks followed by 3 weeks of
ondansetron. Toxicity will be assessed each week of radiation therapy based on the Common
Toxicity Criteria for Adverse Events (CTCAE), version 4.0. The subject will be asked to
complete the modified MASCC Antiemesis Tool (MAT) questionnaire at baseline, and on days 2,
4, and 7 of each week of radiation therapy, as well as to record the use of all study
medication and any antiemetic rescue medication taken daily. At the end of the weeks 3 & 6,
the subject will be asked to fill out a Treatment Satisfaction Questionnaire for Medication
and will be asked at the end of week 6 to choose which antiemetic they prefer.

Inclusion Criteria:

1. Patients must have histologically confirmed diagnosis of malignant glioma
(Glioblastoma, gliosarcoma or anaplastic astrocytoma, or anaplastic
oligodendroglioma) who may or may not be chemotherapy naïve and who are scheduled to
receive radiotherapy (for a total of 60 GY) and concomitant daily temozolomide
therapy (at a dose of 75 mg/m2 for one complete six week cycle).

2. Age ≥ 18 years

3. Karnofsky ≥ 60%

4. Hematocrit > 29%, ANC >1,000 cells/mm3, platelets > 100,000 cells/ mm3

5. Serum creatinine < 1.4 mg/dl, serum SGOT and bilirubin < 1.5 times upper limit of
normal

6. 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

7. Ability and willingness to give informed consent

8. If sexually active, patients will take contraceptive measures for the duration of the
treatments

9. Negative serum pregnancy test 48 hours prior to beginning study drug

Exclusion Criteria:

1. Pregnancy or breastfeeding

2. Co-medication that may interfere with study results; e.g., immune-suppressive agents
other than corticosteroids

3. Inability or unwillingness to cooperate with the study procedures

4. 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

5. Previous participation in any clinical trial involving granisetron

6. Any vomiting, retching, or NCI Common Toxicity Criteria version 4.0 grade 2-4 nausea
in the 24 hours preceding radiation and chemotherapy

7. Ongoing vomiting from any organic etiology

8. Radiotherapy of abdomen within one week prior to or during the study

9. Received granisetron within 14 days prior to study enrollment

10. Prior and concomitant cancer chemotherapy and radiotherapy