Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00293384
Status:
COMPLETED
Last Update Posted:
2016-03-15
First Post:
2006-02-16
Brief Title:
Aprepitant Granisetron Dexamethasone in Preventing Nausea Vomiting in Pts Receiving Cyclophosphamide Before a Stem Cell Transplant
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
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 Progenitor Cell Mobilization Prior to Autologous Transplantation
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA022453 | NIH | None | None |
| WSU-D-2797 | OTHER | None | None |
| WSU-0504001728 | OTHER | Wayne State University - Human Investigation Committee | httpsreporternihgovquickSearchP30CA022453 |