Ondansetron in Preventing Nausea and Vomiting in Patients Undergoing a Stem Cell Transplant
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer; Chronic Myeloproliferative Disorders; Gestational Trophoblastic Tumor; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases; Nausea and Vomiting; Neuroblastoma; Ovarian Cancer; Testicular Germ Cell Tumor
Intervention: ondansetron hydrochloride (Drug); survey administration (Other); autologous hematopoietic stem cell transplantation (Procedure)
Phase: Phase 2
Sponsored by: Fred Hutchinson Cancer Research Center
Official(s) and/or principal investigator(s):
Leona A. Holmberg, MD, PhD, Principal Investigator, Affiliation: Fred Hutchinson Cancer Research Center
RATIONALE: Ondansetron may prevent nausea and vomiting in patients undergoing a autologous
stem cell transplant.
PURPOSE: This phase II trial is studying how well ondansetron works in preventing nausea and
vomiting in patients undergoing a stem cell transplant.
Official title: Prevention of DMSO-Related Nausea and Vomiting by Prophylactic Administration of Ondansetron for Patients Receiving Autologous Cryopreserved Peripheral Blood Stem Cells
Study design: Supportive Care, Open Label
Reduction of nausea to ≤ 25% and vomiting to ≤ 10% related to dimethyl sulfoxide-preserved autologous hematopoietic stem cells
Incidence of nausea and vomiting
- Determine whether a single dose of intravenous ondansetron hydrochloride reduces the
incidence of nausea, retching, and vomiting in patients receiving dimethyl sulfoxide
(DMSO)-preserved autologous peripheral blood stem cells.
- Assess the number of patients who experience nausea, retching, and vomiting related to
DMSO-preserved autologous hematopoietic stem cell administration.
OUTLINE: Patients receive ondansetron hydrochloride IV over 30-60 minutes prior to each
daily autologous peripheral blood stem cell (PBSC) transplantation. Infusion of
cryopreserved PBSC is administered per standard practice guidelines; the cells may not be
washed to remove dimethyl sulfoxide prior to infusion.
Patients complete a nausea survey using the MASCC MAT nausea scale before receiving
ondansetron hydrochloride and after receiving each infusion of cryopreserved PBSC.
Minimum age: 21 Years.
Maximum age: N/A.
- Scheduled to receive autologous peripheral blood stem cell (PBSC) transplantation
- Planned cryopreserved PBSC infusion at the Seattle Cancer Care Alliance (SCCA)
- Cryopreserved PBSC infusion at the University of Washington Medical Center
(UWMC) inpatient unit not allowed
- No allergy or adverse reaction to ondansetron hydrochloride
PRIOR CONCURRENT THERAPY:
- No prior autologous transplantation
Locations and Contacts
Fred Hutchinson Cancer Research Center, Seattle, Washington 98109-1024, United States; Recruiting
Leona A. Holmberg, MD, PhD, Phone: 206-667-6447, Email: firstname.lastname@example.org
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: July 2008
Last updated: September 23, 2009