Efficacy of Aprepitant (Emend®) in Children

1.1 Primary Aim To determine the efficacy of aprepitant (Emend®) in preventing and reducing
chemotherapy-induced nausea and vomiting (CINV) when added to standard antiemetic drug
regimens for children receiving highly emetogenic chemotherapy. The working hypothesis will
be that standard therapy + aprepitant is superior at preventing CINV than standard therapy +
placebo.

1.2 Secondary Aim To evaluate the safety and toxicity of aprepitant (Emend®) in children
receiving highly emetogenic chemotherapy when compared to standard antiemetic therapy +
placebo.

Inclusion Criteria:

under 20.99 years of age at enrollment

Scheduled to receive two identical cycles of highly emetogenic[1] chemotherapy for
treatment of a primary malignancy, including:

Chemotherapy with any one or more of the following single agents in any combination:

- Carboplatin

- Carmustine >250 mg/m2

- Cisplatin

- Cyclophosphamide ≥1 g/m2

- Dactinomycin

Or any of the following defined combinations:

- Cyclophosphamide + anthracycline

- Cyclophosphamide + etoposide

- Cytarabine 150-200 mg/m2 + daunorubicin

- Cytarabine 300 mg/m2 + etoposide

- Cytarabine 300 mg/m2 + teniposide

- Doxorubicin + ifosfamide

- Doxorubicin + methotrexate 5 g/m2

- Etoposide + ifosfamide

Exclusion Criteria:

- Patients who have received aprepitant in the past.

- Patients who demonstrate evidence of increased intracranial pressure.