A Study of Aprepitant (MK0869) and Fosaprepitant (MK0517) in Pediatric Patients Receiving Chemotherapy

Status: Recruiting
Phase:
Diagnosis: Pediatric Brain Tumor, Pediatric Solid Tumors
NCT ID: NCT00818259 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 08-339

 

This study will determine the appropriate dosing regimen of aprepitant and fosaprepitant for the prevention of chemotherapy induced nausea and vomiting in pediatric patients from 6 months to 17 years of age.

 

Conducting Institutions:
Children's Hospital Boston, Dana-Farber Cancer Institute

Overall PI:
Peter Manley, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

Inclusion Criteria: - Patient is scheduled to receive moderately to highly nausea-inducing chemotherapy or patient did not tolerate a previous chemotherapy regimen that is planned to be repeated - Patient will receive ondansetron - Female patients who have begun menstruating must have a negative pregnancy test - Patient weighs at least 6 kg (13.2 lbs) - Patient has a preexisting venous catheter Exclusion Criteria: - Patient uses any illicit drugs or abuses alcohol - Patient is pregnant or breast feeding - Patient has a symptomatic CNS tumor - Patient has an infection or other uncontrolled disease other than cancer
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