Clinical Trial: Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Pilot Study Evaluating Aprepitant (MK-869) for Prevention of Nausea & Vomiting Secondary to High Dose Cyclophosphamide Administered to Patients Underging Undergoing Peripheral Hematopoietic Progen

Brief Summary:

RATIONALE: Antiemetic drugs, such as aprepitant, granisetron, and dexamethasone, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy.

PURPOSE: This clinical trial is studying how well giving aprepitant together with granisetron and dexamethasone works in preventing nausea and vomiting in patients receiving cyclophosphamide before undergoing an autologous stem cell transplant.


Detailed Summary:

OBJECTIVES:

Primary

  • 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.

Secondary

  • Evaluate the efficacy of the addition of aprepitant in controlling delayed vomiting in these patients.
  • Evaluate the efficacy of the addition of aprepitant in controlling overall nausea in these patients.
  • 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 toxicity.

After completion of study treatment, patients are followed for 30 days.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.


Sponsor: Barbara Ann Karmanos Cancer Institute

Current Primary Outcome: Proportion of Participants With Controlled Acute Vomiting [ Time Frame: at 0-24 hours ]

No episodes of vomiting and no rescue medication during first 24 hours after cyclophosphamide administration.


Original Primary Outcome:

Current Secondary Outcome:

  • Delayed Vomiting Controlled [ Time Frame: at 25-120 hours ]
  • Toxicity Grade 3, 4, or 5 [ Time Frame: at 0-120 hours ]


Original Secondary Outcome:

Information By: Barbara Ann Karmanos Cancer Institute

Dates:
Date Received: February 16, 2006
Date Started: October 2004
Date Completion:
Last Updated: February 12, 2016
Last Verified: February 2016