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

Primary Purpose

Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ondansetron
survey administration
management of therapy complications
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Accelerated Phase Chronic Myelogenous Leukemia

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ondansetron therapy

Arm Description

Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.

Outcomes

Primary Outcome Measures

Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates)
Nausea Multinational Association of Supportive Care in Cancer Antiemesis Tool™ (MAT). Increased MAT scores represent worse outcome (score 0-10). Vomiting represented as present or absent.

Secondary Outcome Measures

Full Information

First Posted
November 20, 2008
Last Updated
April 20, 2017
Sponsor
Fred Hutchinson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00795769
Brief Title
Ondansetron in Preventing Nausea and Vomiting in Patients Undergoing 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 Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 8, 2008 (Actual)
Primary Completion Date
June 9, 2009 (Actual)
Study Completion Date
June 10, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fred Hutchinson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Ondansetron may help lessen or prevent nausea and vomiting in patients undergoing stem cell transplant. PURPOSE: This phase II trial is studying how well ondansetron works in preventing nausea and vomiting in patients undergoing stem cell transplant.
Detailed Description
OBJECTIVES: I. To determine whether the incidence of nausea 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ondansetron therapy
Arm Type
Experimental
Arm Description
Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.
Intervention Type
Drug
Intervention Name(s)
ondansetron
Other Intervention Name(s)
GR 38032F, GR-C507/75, Zofran
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
survey administration
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
management of therapy complications
Other Intervention Name(s)
complications of therapy, management of
Intervention Description
Ondansetron IV
Primary Outcome Measure Information:
Title
Reduction in Rates of Nausea or Vomiting After Ondansetron (Compared to FHCRC Historical Rates)
Description
Nausea Multinational Association of Supportive Care in Cancer Antiemesis Tool™ (MAT). Increased MAT scores represent worse outcome (score 0-10). Vomiting represented as present or absent.
Time Frame
Baseline up to 120 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leona Holmberg
Organizational Affiliation
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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