Efficacy of Aprepitant (Emend®) in Children

• Status: Completed
• Trial end date: 2017-06-29
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find out whether or not adding aprepitant(Emend®) to the standard therapy will help children who receive chemotherapy to have less nausea and vomiting.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oklahoma
• Treatments: Antiemetics; Aprepitant; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Fosaprepitant; Ondansetron

Criteria

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

• High dose Methotrexate ≥ 5 g/m2

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.