Ondansetron in Preventing Nausea and Vomiting in Patients Undergoing a Stem Cell Transplant

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

Status: Recruiting

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

Primary outcome:

Reduction of nausea to ≤ 25% and vomiting to ≤ 10% related to dimethyl sulfoxide-preserved autologous hematopoietic stem cells

Incidence of nausea and vomiting

Detailed description: OBJECTIVES:

- 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. Gender(s): Both.

Criteria:

DISEASE CHARACTERISTICS:

- Scheduled to receive autologous peripheral blood stem cell (PBSC) transplantation

- Planned cryopreserved PBSC infusion at the Seattle Cancer Care Alliance (SCCA)

outpatient clinic

- Cryopreserved PBSC infusion at the University of Washington Medical Center

(UWMC) inpatient unit not allowed

PATIENT CHARACTERISTICS:

- English-speaking

- No allergy or adverse reaction to ondansetron hydrochloride

PRIOR CONCURRENT THERAPY:

- No prior autologous transplantation

Fred Hutchinson Cancer Research Center, Seattle, Washington 98109-1024, United States; Recruiting
Leona A. Holmberg, MD, PhD, Phone: 206-667-6447, Email: lholmber@fhcrc.org

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: July 2008
Last updated: September 23, 2009