Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant
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.
|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||Drug: Aprepitant Drug: Cyclophosphamide Drug: Dexamethasone Drug: Granisetron hydrochloride|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|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|
- 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.
- Delayed Vomiting Controlled [ Time Frame: at 25-120 hours ]
- Toxicity Grade 3, 4, or 5 [ Time Frame: at 0-120 hours ]
- Overall Nausea Controlled [ Time Frame: at 0-120 hours ]
|Study Start Date:||October 2004|
|Study Completion Date:||February 2012|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Experimental: Aprepitant, Dexamethasone, Cytoxan & Kytril
Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.
Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.
Days 2 & 3: Aprepitant 80 mg once daily in the morning.
Aprepitant 80mg once daily in the morning on days 2 and 3
Other Name: EmendDrug: Cyclophosphamide
Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes
Other Names:Drug: Dexamethasone
Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.
Other Names:Drug: Granisetron hydrochloride
Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.
Other Name: KYTRIL®
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00293384
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|Study Chair:||Muneer H. Abidi, MD||Barbara Ann Karmanos Cancer Institute|