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

Fred Hutchinson Cancer Center (FHCC)

Status and phase

Completed

Phase 2

Conditions

Stage IIIA Breast Cancer

Stage III Mantle Cell Lymphoma

Stage IV Marginal Zone Lymphoma

Chronic Neutrophilic Leukemia

Recurrent Adult Diffuse Small Cleaved Cell Lymphoma

Noncontiguous Stage II Grade 1 Follicular Lymphoma

Recurrent Ovarian Germ Cell Tumor

Noncontiguous Stage II Mantle Cell Lymphoma

Recurrent Grade 3 Follicular Lymphoma

Recurrent Marginal Zone Lymphoma

Stage III Grade 3 Follicular Lymphoma

Recurrent Grade 1 Follicular Lymphoma

Recurrent Mantle Cell Lymphoma

Stage I Multiple Myeloma

Recurrent/Refractory Childhood Hodgkin Lymphoma

Stage III Adult Diffuse Mixed Cell Lymphoma

Noncontiguous Stage II Small Lymphocytic Lymphoma

Chronic Myelomonocytic Leukemia

Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)

Stage III Adult Diffuse Large Cell Lymphoma

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities

Stage III Adult Burkitt Lymphoma

Stage III Adult Diffuse Small Cleaved Cell Lymphoma

Recurrent Grade 2 Follicular Lymphoma

Recurrent Ovarian Epithelial Cancer

Recurrent Malignant Testicular Germ Cell Tumor

Stage III Multiple Myeloma

Stage III Marginal Zone Lymphoma

Refractory Hairy Cell Leukemia

Stage IV Adult Diffuse Mixed Cell Lymphoma

Stage IV Ovarian Epithelial Cancer

Stage IV Adult Hodgkin Lymphoma

Stage IIIB Breast Cancer

Stage III Ovarian Epithelial Cancer

Recurrent Adult Immunoblastic Large Cell Lymphoma

Recurrent Adult Acute Lymphoblastic Leukemia

Recurrent Adult Lymphoblastic Lymphoma

Stage III Small Lymphocytic Lymphoma

Stage IV Adult Diffuse Large Cell Lymphoma

Poor Prognosis Metastatic Gestational Trophoblastic Tumor

Stage IV Adult Immunoblastic Large Cell Lymphoma

Noncontiguous Stage II Grade 2 Follicular Lymphoma

Secondary Myelodysplastic Syndromes

Disseminated Neuroblastoma

Stage IV Adult Burkitt Lymphoma

Stage IV Chronic Lymphocytic Leukemia

Stage II Ovarian Epithelial Cancer

Recurrent Adult Acute Myeloid Leukemia

Stage II Multiple Myeloma

Stage IV Small Lymphocytic Lymphoma

Recurrent Neuroblastoma

Stage IV Adult Diffuse Small Cleaved Cell Lymphoma

Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue

Splenic Marginal Zone Lymphoma

Chronic Eosinophilic Leukemia

Noncontiguous Stage II Marginal Zone Lymphoma

Adult Acute Myeloid Leukemia in Remission

Stage IV Adult Lymphoblastic Lymphoma

Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma

Blastic Phase Chronic Myelogenous Leukemia

Stage III Chronic Lymphocytic Leukemia

Stage III Adult Immunoblastic Large Cell Lymphoma

Recurrent Small Lymphocytic Lymphoma

Stage III Adult Hodgkin Lymphoma

Stage III Adult Lymphoblastic Lymphoma

Accelerated Phase Chronic Myelogenous Leukemia

Nodal Marginal Zone B-cell Lymphoma

Recurrent Adult Burkitt Lymphoma

Noncontiguous Stage II Adult Lymphoblastic Lymphoma

Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma

Recurrent Mycosis Fungoides/Sezary Syndrome

Noncontiguous Stage II Adult Burkitt Lymphoma

Chronic Phase Chronic Myelogenous Leukemia

Recurrent Childhood Small Noncleaved Cell Lymphoma

Stage III Grade 1 Follicular Lymphoma

Stage III Grade 2 Follicular Lymphoma

Recurrent Adult Hodgkin Lymphoma

Stage IV Grade 2 Follicular Lymphoma

Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)

Previously Treated Myelodysplastic Syndromes

Relapsing Chronic Myelogenous Leukemia

Recurrent Adult Diffuse Mixed Cell Lymphoma

Refractory Chronic Lymphocytic Leukemia

Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma

Stage IIIC Breast Cancer

Stage IV Grade 3 Follicular Lymphoma

Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma

Stage III Malignant Testicular Germ Cell Tumor

de Novo Myelodysplastic Syndromes

Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)

Recurrent Adult Diffuse Large Cell Lymphoma

Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma

Adult Acute Lymphoblastic Leukemia in Remission

Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable

Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)

Noncontiguous Stage II Grade 3 Follicular Lymphoma

Recurrent Childhood Lymphoblastic Lymphoma

Stage IV Mantle Cell Lymphoma

Primary Myelofibrosis

Secondary Acute Myeloid Leukemia

Recurrent Childhood Large Cell Lymphoma

Atypical Chronic Myeloid Leukemia, BCR-ABL Negative

Stage IV Grade 1 Follicular Lymphoma

Stage IV Breast Cancer

Treatments

Procedure: management of therapy complications

Drug: ondansetron

Other: survey administration

Study type

Interventional

Funder types

Other

Identifiers

NCT00795769

NCI-2010-00325 (Registry Identifier)

2247.00

Details and patient eligibility

About

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.

Full 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.

Enrollment

49 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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