NCT00293384

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Breast Cancer
• Chronic Myeloproliferative Disorders
• Gestational Trophoblastic Tumor
• Leukemia
• Lymphoma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic/Myeloproliferative Neoplasms
• Nausea and Vomiting
• Neuroblastoma
• Ovarian Cancer
• Testicular Germ Cell Tumor

Interventions

Type	Name	Description
DRUG	Aprepitant	Aprepitant 80mg once daily in the morning on days 2 and 3
DRUG	Cyclophosphamide	Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes
DRUG	Dexamethasone	Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.
DRUG	Granisetron hydrochloride	Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.

Timeline

• Start date: 2004-10-01
• Primary completion: 2009-06-01
• Completion: 2012-02-01
• First posted: 2006-02-17
• Last updated: 2016-03-15
• Results posted: 2014-10-03

Locations

1 site across 1 country: United States