Patient Satisfaction, Efficacy and Compliance of Antiemetic Patch vs Pill in Malignant Glioma Patients
Patient Satisfaction, Efficacy and Compliance of Antiemetic Patch vs Pill in Malignant Glioma Patients
The purpose of this study is to assess patient satisfaction, the efficacy and compliance of
 granisetron patch versus ondansetron pills for radiation induced nausea and vomiting in
 malignant glioma patients receiving six weeks of radiation therapy (RT) and concomitant
 temozolomide (TMZ). Use of the patch may benefit brain tumor patients by increasing
 compliance.

 All eligible adult malignant glioma subjects should receive a planned total dose of 54-60 GY
 of radiation and 75 mg/m2 of daily TMZ for a total of six weeks. Subjects will be randomized
 to receive either granisetron patch or ondansetron for three weeks. Weeks 3-6, they will
 received the other medication. The granisetron transdermal delivery system (supplied as a 52
 cm^2 patch containing 34.3 mg of granisetron - 3.1 mg/day) is applied once per week 24 hours
 before the weekly radiation and chemotherapy, while the ondansetron 8 mg oral tablet is taken
 once a day 30-60 minutes prior to each dose of chemotherapy. Subjects will fill out
 questionnaires regarding the effectiveness of the medication and their satisfaction, and
 which anti-emetic they prefer.

 Safety will be assessed throughout the six weeks of radiation by the clinical research nurse
 using the Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. All subjects who
 receive both ondansetron and Granisetron Transdermal Delivery System (GTDS) treatment will be
 included in analyses of treatment preference. However, all other efficacy and safety analyses
 will include all subjects who received ondansetron or GTDS.
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