Trial Information
Prevention of DMSO-Related Nausea and Vomiting by Prophylactic Administration of Ondansetron for Patients Receiving Autologous Cryopreserved Peripheral Blood Stem Cells
OBJECTIVES:
I. To determine whether the incidence of nausea, retching and vomiting related to
administration of autologous hematopoetic stem cells cryopreserved in DMSO can be reduced by
the use of a single dose of intravenous ondansetron prior to the stem cell infusion.
II. To determine the number of patients who experience nausea and vomiting.
OUTLINE: Patients receive ondansetron IV once 30-60 minutes before undergoing autologous
peripheral blood stem cell transplantation.
Inclusion Criteria
Inclusion
- Autologous PBSC transplant patient
- English-speaking
- Planned cryopreserved PBSC infusion at the SCCA outpatient clinic
Exclusion
- History of prior autologous transplant
- Non-English-speaking
- Planned cryopreserved PBSC infusion at the UWMC inpatient unit
- Infusion of cryopreserved PBSC that are thawed and washed to remove DMSO prior to
infusion
- Allergy or adverse reaction to ondansetron
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Reduction in rates of nausea or vomiting after ondansetron (compared to historical rates)
Outcome Time Frame:
With stem cell infusion
Safety Issue:
No
Principal Investigator
Leona Holmberg
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Authority:
United States: Federal Government
Study ID:
2247.00
NCT ID:
NCT00795769
Start Date:
August 2008
Completion Date:
Related Keywords:
- Accelerated Phase Chronic Myelogenous Leukemia
- Adult Acute Lymphoblastic Leukemia in Remission
- Adult Acute Myeloid Leukemia in Remission
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
- Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
- Atypical Chronic Myeloid Leukemia, BCR-ABL Negative
- Blastic Phase Chronic Myelogenous Leukemia
- Chronic Eosinophilic Leukemia
- Chronic Myelomonocytic Leukemia
- Chronic Neutrophilic Leukemia
- Chronic Phase Chronic Myelogenous Leukemia
- de Novo Myelodysplastic Syndromes
- Disseminated Neuroblastoma
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
- Nodal Marginal Zone B-cell Lymphoma
- Noncontiguous Stage II Adult Burkitt Lymphoma
- Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
- Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma
- Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
- Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma
- Noncontiguous Stage II Adult Lymphoblastic Lymphoma
- Noncontiguous Stage II Grade 1 Follicular Lymphoma
- Noncontiguous Stage II Grade 2 Follicular Lymphoma
- Noncontiguous Stage II Grade 3 Follicular Lymphoma
- Noncontiguous Stage II Mantle Cell Lymphoma
- Noncontiguous Stage II Marginal Zone Lymphoma
- Noncontiguous Stage II Small Lymphocytic Lymphoma
- Poor Prognosis Metastatic Gestational Trophoblastic Tumor
- Previously Treated Myelodysplastic Syndromes
- Primary Myelofibrosis
- Recurrent Adult Acute Lymphoblastic Leukemia
- Recurrent Adult Acute Myeloid Leukemia
- Recurrent Adult Burkitt Lymphoma
- Recurrent Adult Diffuse Large Cell Lymphoma
- Recurrent Adult Diffuse Mixed Cell Lymphoma
- Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
- Recurrent Adult Hodgkin Lymphoma
- Recurrent Adult Immunoblastic Large Cell Lymphoma
- Recurrent Adult Lymphoblastic Lymphoma
- Recurrent Childhood Large Cell Lymphoma
- Recurrent Childhood Lymphoblastic Lymphoma
- Recurrent Childhood Small Noncleaved Cell Lymphoma
- Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
- Recurrent Grade 1 Follicular Lymphoma
- Recurrent Grade 2 Follicular Lymphoma
- Recurrent Grade 3 Follicular Lymphoma
- Recurrent Malignant Testicular Germ Cell Tumor
- Recurrent Mantle Cell Lymphoma
- Recurrent Marginal Zone Lymphoma
- Recurrent Mycosis Fungoides/Sezary Syndrome
- Recurrent Neuroblastoma
- Recurrent Ovarian Epithelial Cancer
- Recurrent Ovarian Germ Cell Tumor
- Recurrent Small Lymphocytic Lymphoma
- Recurrent/Refractory Childhood Hodgkin Lymphoma
- Refractory Chronic Lymphocytic Leukemia
- Refractory Hairy Cell Leukemia
- Relapsing Chronic Myelogenous Leukemia
- Secondary Acute Myeloid Leukemia
- Secondary Myelodysplastic Syndromes
- Splenic Marginal Zone Lymphoma
- Stage I Multiple Myeloma
- Stage II Multiple Myeloma
- Stage II Ovarian Epithelial Cancer
- 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 Chronic Lymphocytic Leukemia
- Stage III Grade 1 Follicular Lymphoma
- Stage III Grade 2 Follicular Lymphoma
- Stage III Grade 3 Follicular Lymphoma
- Stage III Malignant Testicular Germ Cell Tumor
- Stage III Mantle Cell Lymphoma
- Stage III Marginal Zone Lymphoma
- Stage III Multiple Myeloma
- Stage III Ovarian Epithelial Cancer
- Stage III Small Lymphocytic Lymphoma
- Stage IIIA Breast Cancer
- Stage IIIB Breast Cancer
- Stage IIIC Breast Cancer
- 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 Breast Cancer
- Stage IV Chronic Lymphocytic Leukemia
- 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 Ovarian Epithelial Cancer
- Stage IV Small Lymphocytic Lymphoma
- Congenital Abnormalities
- Primary Myelofibrosis
- Blast Crisis
- Breast Neoplasms
- Burkitt Lymphoma
- Neoplasms
- Hodgkin Disease
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Hairy Cell
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
- Leukemia, Myeloid, Accelerated Phase
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Leukemia, Myeloid, Chronic-Phase
- Leukemia, Myelomonocytic, Chronic
- Leukemia, Neutrophilic, Chronic
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Mycoses
- Mycosis Fungoides
- Myelodysplastic Syndromes
- Preleukemia
- Leukemia, Myelomonocytic, Acute
- Myeloproliferative Disorders
- Neuroblastoma
- Sezary Syndrome
- Testicular Neoplasms
- Trophoblastic Neoplasms
- Vomiting
- Lymphoma, B-Cell
- Lymphoma, Large-Cell, Immunoblastic
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Cutaneous
- Neoplasms, Germ Cell and Embryonal
- Hypereosinophilic Syndrome
- Germinoma
- Ovarian Neoplasms
- Lymphoma, B-Cell, Marginal Zone
- Lymphoma, Mantle-Cell
- Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
- Neoplasms, Glandular and Epithelial
- Gestational Trophoblastic Neoplasms
- Myelodysplastic-Myeloproliferative Diseases
Name | Location |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
Seattle, Washington 98109 |