Overview

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

Status:
Withdrawn

Trial end date:
1969-12-31

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Duke University

Collaborator:

Prostrakan Pharmaceuticals

Treatments:

Antiemetics
Granisetron
Ondansetron

Criteria

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