Pilot Study Evaluating Aprepitant (MK-869) for Prevention of Nausea & Vomiting Secondary to High Dose Cyclophosphamide Administered to Patients Underging Undergoing Peripheral Hematopoietic Progenitor Cell Mobilization Prior to Autologous Transplantation
- Evaluate the efficacy of the addition of aprepitant in controlling acute vomiting with
the standard prophylactic anti-emetic combination of granisetron hydrochloride and
dexamethasone in patients receiving therapy comprising high-dose cyclophosphamide to
mobilize stem cells prior to leukapheresis for autologous stem cell transplantation.
- Evaluate the efficacy of the addition of aprepitant in controlling delayed vomiting in
- Evaluate the efficacy of the addition of aprepitant in controlling overall nausea in
- Identify side effects of the addition of aprepitant to this regimen in these patients.
OUTLINE: Patients receive granisetron hydrochloride orally or IV and oral dexamethasone,
followed 1 hour later by cyclophosphamide IV over 2 hours on day 1. Patients also receive
oral aprepitant once daily on days 1-3. Treatment continues in absence of unacceptable
After completion of study treatment, patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Acute vomiting controlled
at 0-24 hours
Muneer H. Abidi, MD
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|