Ondansetron with or without Aprepitant in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients with Gliomas

Inclusion Criteria

• Patients must have histologically confirmed diagnosis of glioma (either low or high grade) and be either chemotherapy naive or non-naive and scheduled to receive temozolomide-based +/- bevacizumab-based chemotherapy; patients with recurrent disease whose diagnostic pathology confirmed glioma (either low or high grade) will not need re-biopsy
• =< 2 prior chemotherapeutic regimens
• Patient is scheduled to receive adjuvant temozolomide at either 150 mg/m^2 or 200 mg/m^2 PO x 5 days out of a 28 day cycle +/- bevacizumab
• Study participation will occur during the first cycle of 5 day temozolomide course
• An interval of at least 6 weeks between prior surgical resection and study enrollment
• Karnofsky >= 60%
• Hematocrit > 29%
• Absolute neutrophil count (ANC) > 1,000 cells/ul
• Platelets > 100,000 cells/ul
• Serum creatinine < 1.5 mg/dl
• Serum glutamic oxaloacetic transaminase (SGOT) < 1.5 times upper limit of normal
• Serum bilirubin < 1.5 times upper limit of normal
• For patients on oral corticosteroids, they must be stable clinically on corticosteroids or tapered off prior to starting the study drug; for patients taking dexamethasone, the dose should not exceed 8 mg QD (or 4 mg twice daily [BID]), if clinically stable, and the dose should not be escalated over entry dose level, if clinically possible; the patient’s dose of dexamethasone will be evaluated by the principal investigator (PI), the patient’s study physician, and/or the study pharmacist on a case by case basis for safety; all doses of oral corticosteroids will be reduced by 50%, unless oral corticosteroids are at physiologic dose (e.g. dexamethasone 1 mg, prednisone 10 mg, or cortisone 30 mg); it is recommended that oral corticosteroid doses be escalated back to full dose on day 7 (2 days after aprepitant is discontinued)
• Signed informed consent approved by the Institutional Review Board prior to patient entry
• If sexually active, patients will take contraceptive measures for the duration of protocol treatment and continue until one month after treatment; the efficacy of hormonal contraceptives during and for 28 days following the last dose of aprepitant may be reduced; alternative or back-up methods of contraception must be used
• Approved rescue medication for the treatment of nausea and vomiting is permitted at the discretion of the investigator; the rescue antiemetics allowed will include: ondansetron, granisetron and lorazepam

Exclusion Criteria

• Pregnant or breast-feeding
• No prior nitrosourea (e.g. lomustine, carmustine)
• Inability or unwillingness to understand or cooperate with study procedures
• Concurrent administration of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) enzyme-inducing anti-epileptic drugs (EIAEDs) including phenytoin, phenobarbital, carbamazepine, oxcarbazepine or primidone
• Prohibited medications: patients taking CYP3A4 enzyme inducers and moderate or strong inhibitors will be excluded from this trial
• Received any drug with potential anti-emetic effect within 24 hours prior to the start of study-designated chemotherapeutic agent: 5-hydroxytryptamine type 3 (HT3) receptor or substance P/neurokinin 1(NK1) receptor antagonists; dopamine receptor antagonists (metoclopramide); phenothiazine anti-emetics (prochlorperazine, thiethylperazine and perphenazine); diphenhydramine, scopolamine, chlorpheniramine maleate, trimethobenzamide; haloperidol, droperidol, tetrahydrocannabinol, or nabilone
• Any vomiting, retching or National Cancer Institute (NCI) Common Toxicity Criteria version 4.0 grade 2-4 nausea 24 hours preceding chemotherapy
• Ongoing vomiting from any organic etiology
• Will receive radiotherapy of cranium within one week prior to or during the study