Ondansetron in Preventing Nausea and Vomiting in Patients Undergoing a Stem Cell Transplant - Full Text View

Sponsor:	Fred Hutchinson Cancer Research Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00795769

Purpose

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.

Condition	Intervention	Phase
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	Drug: ondansetron hydrochloride Other: survey administration Procedure: autologous hematopoietic stem cell transplantation	Phase II

Study Type:	Interventional
Study Design:	Supportive Care, Open Label
Official Title:	Prevention of DMSO-Related Nausea and Vomiting by Prophylactic Administration of Ondansetron for Patients Receiving Autologous Cryopreserved Peripheral Blood Stem Cells

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia breast cancer hemophilia

MedlinePlus related topics: Breast Cancer Cancer Hodgkin Disease Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma Nausea and Vomiting Neuroblastoma Ovarian Cancer

Drug Information available for: Ondansetron hydrochloride Ondansetron

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Reduction of nausea to ≤ 25% and vomiting to ≤ 10% related to dimethyl sulfoxide-preserved autologous hematopoietic stem cells [ Designated as safety issue: No ]
Incidence of nausea and vomiting [ Designated as safety issue: Yes ]

Estimated Enrollment:	51
Study Start Date:	July 2008
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795769

Locations

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

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Leona A. Holmberg, MD, PhD

Fred Hutchinson Cancer Research Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Fred Hutchinson Cancer Research Center ( Leona A. Holmberg )
Study ID Numbers:	CDR0000616920, FHCRC-2247.00, IR-6765
Study First Received:	November 20, 2008
Last Updated:	September 23, 2009
ClinicalTrials.gov Identifier:	NCT00795769 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

nausea and vomiting
stage III adult Burkitt lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult Hodgkin lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III mantle cell lymphoma
stage III marginal zone lymphoma
stage III small lymphocytic lymphoma
stage IV adult Burkitt lymphoma

stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult Hodgkin lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV mantle cell lymphoma
stage IV marginal zone lymphoma
stage IV small lymphocytic lymphoma
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma

Additional relevant MeSH terms:

Neurotransmitter Agents
Neuroectodermal Tumors, Primitive
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Physiological Effects of Drugs
Antiemetics
Urogenital Neoplasms
Serotonin Antagonists
Preleukemia
Pathologic Processes
Neoplasms by Site
Hemorrhagic Disorders
Therapeutic Uses
Antipruritics
Cardiovascular Diseases

Dermatologic Agents
Breast Diseases
Endocrine Gland Neoplasms
Tranquilizing Agents
Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases
Genital Neoplasms, Female
Myeloproliferative Disorders
Endocrine System Diseases
Breast Neoplasms
Antipsychotic Agents
Multiple Myeloma
Neuroectodermal Tumors
Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010