NCT00795769

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2009

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2009

Completed
8 years until next milestone

Results Posted

Study results publicly available

May 23, 2017

Completed
Last Updated

May 23, 2017

Status Verified

April 1, 2017

Enrollment Period

10 months

First QC Date

November 20, 2008

Results QC Date

March 6, 2017

Last Update Submit

April 20, 2017

Conditions

Accelerated Phase Chronic Myelogenous LeukemiaAdult Acute Lymphoblastic Leukemia in RemissionAdult Acute Myeloid Leukemia in RemissionAdult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult 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 NegativeBlastic Phase Chronic Myelogenous LeukemiaChronic Eosinophilic LeukemiaChronic Myelomonocytic LeukemiaChronic Neutrophilic LeukemiaChronic Phase Chronic Myelogenous Leukemiade Novo Myelodysplastic SyndromesDisseminated NeuroblastomaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueMyelodysplastic/Myeloproliferative Neoplasm, UnclassifiableNodal Marginal Zone B-cell LymphomaNoncontiguous Stage II Adult Burkitt LymphomaNoncontiguous Stage II Adult Diffuse Large Cell LymphomaNoncontiguous Stage II Adult Diffuse Mixed Cell LymphomaNoncontiguous Stage II Adult Diffuse Small Cleaved Cell LymphomaNoncontiguous Stage II Adult Immunoblastic Large Cell LymphomaNoncontiguous Stage II Adult Lymphoblastic LymphomaNoncontiguous Stage II Grade 1 Follicular LymphomaNoncontiguous Stage II Grade 2 Follicular LymphomaNoncontiguous Stage II Grade 3 Follicular LymphomaNoncontiguous Stage II Mantle Cell LymphomaNoncontiguous Stage II Marginal Zone LymphomaNoncontiguous Stage II Small Lymphocytic LymphomaPoor Prognosis Metastatic Gestational Trophoblastic TumorPreviously Treated Myelodysplastic SyndromesPrimary MyelofibrosisRecurrent Adult Acute Lymphoblastic LeukemiaRecurrent Adult Acute Myeloid LeukemiaRecurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Diffuse Mixed Cell LymphomaRecurrent Adult Diffuse Small Cleaved Cell LymphomaRecurrent Adult Hodgkin LymphomaRecurrent Adult Immunoblastic Large Cell LymphomaRecurrent Adult Lymphoblastic LymphomaRecurrent Childhood Large Cell LymphomaRecurrent Childhood Lymphoblastic LymphomaRecurrent Childhood Small Noncleaved Cell LymphomaRecurrent Cutaneous T-cell Non-Hodgkin LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Malignant Testicular Germ Cell TumorRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaRecurrent Mycosis Fungoides/Sezary SyndromeRecurrent NeuroblastomaRecurrent Ovarian Epithelial CancerRecurrent Ovarian Germ Cell TumorRecurrent Small Lymphocytic LymphomaRecurrent/Refractory Childhood Hodgkin LymphomaRefractory Chronic Lymphocytic LeukemiaRefractory Hairy Cell LeukemiaRelapsing Chronic Myelogenous LeukemiaSecondary Acute Myeloid LeukemiaSecondary Myelodysplastic SyndromesSplenic Marginal Zone LymphomaStage I Multiple MyelomaStage II Multiple MyelomaStage II Ovarian Epithelial CancerStage III Adult Burkitt LymphomaStage III Adult Diffuse Large Cell LymphomaStage III Adult Diffuse Mixed Cell LymphomaStage III Adult Diffuse Small Cleaved Cell LymphomaStage III Adult Hodgkin LymphomaStage III Adult Immunoblastic Large Cell LymphomaStage III Adult Lymphoblastic LymphomaStage III Chronic Lymphocytic LeukemiaStage III Grade 1 Follicular LymphomaStage III Grade 2 Follicular LymphomaStage III Grade 3 Follicular LymphomaStage III Malignant Testicular Germ Cell TumorStage III Mantle Cell LymphomaStage III Marginal Zone LymphomaStage III Multiple MyelomaStage III Ovarian Epithelial CancerStage III Small Lymphocytic LymphomaStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast CancerStage IV Adult Burkitt LymphomaStage IV Adult Diffuse Large Cell LymphomaStage IV Adult Diffuse Mixed Cell LymphomaStage IV Adult Diffuse Small Cleaved Cell LymphomaStage IV Adult Hodgkin LymphomaStage IV Adult Immunoblastic Large Cell LymphomaStage IV Adult Lymphoblastic LymphomaStage IV Breast CancerStage IV Chronic Lymphocytic LeukemiaStage IV Grade 1 Follicular LymphomaStage IV Grade 2 Follicular LymphomaStage IV Grade 3 Follicular LymphomaStage IV Mantle Cell LymphomaStage IV Marginal Zone LymphomaStage IV Ovarian Epithelial CancerStage IV Small Lymphocytic Lymphoma

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline up to 120 minutes

Study Arms (1)

Ondansetron therapy

EXPERIMENTAL

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

Drug: ondansetronOther: survey administrationProcedure: management of therapy complications

Interventions

ondansetronDRUG

Given IV

Also known as: GR 38032F, GR-C507/75, Zofran
Ondansetron therapy
survey administrationOTHER

Correlative studies

Ondansetron therapy
management of therapy complicationsPROCEDURE

Ondansetron IV

Also known as: complications of therapy, management of
Ondansetron therapy

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Autologous PBSC transplant patient
  • English-speaking
  • Planned cryopreserved PBSC infusion at the SCCA outpatient clinic

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Accelerated PhaseCongenital AbnormalitiesLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeBlast CrisisPdgfra-Associated Chronic Eosinophilic LeukemiaLeukemia, Myelomonocytic, ChronicLeukemia, Neutrophilic, ChronicLeukemia, Myeloid, Chronic-PhaseMyeloproliferative DisordersLymphoma, B-Cell, Marginal ZonePrimary MyelofibrosisPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticDendritic Cell Sarcoma, InterdigitatingLymphoma, T-Cell, CutaneousLymphoma, FollicularTesticular NeoplasmsLymphoma, Mantle-CellMycosis FungoidesSezary SyndromeNeuroblastomaCarcinoma, Ovarian EpithelialLeukemia, Lymphocytic, Chronic, B-CellRecurrenceLeukemia, Hairy CellMultiple MyelomaBreast Neoplasms

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMyelodysplastic-Myeloproliferative DiseasesCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLymphoma, B-CellLymphomaLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsHistiocytic Disorders, MalignantHistiocytosisLymphoma, T-CellEndocrine Gland NeoplasmsNeoplasms by SiteGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal DisordersNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCarcinomaOvarian NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Neoplasms, FemaleLeukemia, B-CellNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Results Point of Contact

Title
Dr. Leona A. Holmberg
Organization
Fred Hutchinson Cancer Research Center
lholmber@fredhutch.org
206-667-6447

Study Officials

  • Leona Holmberg

    Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2008

First Posted

November 21, 2008

Study Start

August 8, 2008

Primary Completion

June 9, 2009

Study Completion

June 10, 2009

Last Updated

May 23, 2017

Results First Posted

May 23, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)