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Phase II Study of Ondansetron Hydrochloride for the Prevention of Dimethyl Sulfoxide-Related Nausea and Vomiting in Patients Receiving Cryopreserved Autologous Peripheral Blood Stem Cells

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Supportive care Active 21 and over NCI FHCRC-2247.00
FHCRC-2247.00, IR-6765, NCT00795769

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.

Entry 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

Prior/Concurrent Therapy:

No prior autologous transplantation

Patient Characteristics:

English-speaking
No allergy or adverse reaction to ondansetron hydrochloride

Expected Enrollment

Outcomes

Primary Outcome(s)

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

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.

Trial Contact Information

Trial Lead Organizations

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Leona Holmberg, MD, PhD, Principal investigator
Ph: 206-667-6447
Email: lholmber@fhcrc.org

Trial Sites

U.S.A.

Washington

Seattle

Fred Hutchinson Cancer Research Center

Leona Holmberg, MD, PhD
Ph: 206-667-6447

Email: lholmber@fhcrc.org

Registry Information

Official Title		Prevention of DMSO-Related Nausea and Vomiting by Prophylactic Administration of Ondansetron for Patients Receiving Autologous Cryopreserved Peripheral Blood Stem Cells

Trial Start Date		2008-07-23

Trial Completion Date		2010-12-31 (estimated)

Registered in ClinicalTrials.gov		NCT00795769

Date Submitted to PDQ		2008-10-06

Information Last Verified		2009-07-16

NCI Grant/Contract Number		CA15704

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.