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| Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center 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 Procedure: autologous hematopoietic stem cell transplantation Procedure: survey administration |
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 |
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2008 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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 |
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
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and 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 | |
| Principal Investigator: | Leona A. Holmberg, MD, PhD | Fred Hutchinson Cancer Research Center |
More Information
| 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: | December 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00795769 |
| Health Authority: | Unspecified |
|
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 |
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Blast Crisis Sezary syndrome Chronic myelogenous leukemia Hodgkin lymphoma, adult Lymphoma, small cleaved-cell, diffuse Urogenital Neoplasms Lymphoma, large-cell, immunoblastic Preleukemia Hemorrhagic Disorders Neoplasm Metastasis Neuroepithelioma Endocrine Gland Neoplasms Myelodysplastic syndromes Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases |
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Blood Coagulation Disorders Genital Neoplasms, Female Acute myelogenous leukemia Breast Neoplasms Testicular Neoplasms Leukemia, Myeloid Serotonin Myelodysplastic myeloproliferative disease Leukemia, Myeloid, Accelerated Phase B-cell lymphomas Lymphoma, Non-Hodgkin Hairy cell leukemia Neoplasms, Glandular and Epithelial |
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Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neoplasms, Nerve Tissue Physiological Effects of Drugs Psychotropic Drugs Antiemetics Serotonin Antagonists Pathologic Processes Neoplasms by Site Syndrome Therapeutic Uses Antipruritics Cardiovascular Diseases Dermatologic Agents Tranquilizing Agents |
Pregnancy Complications, Neoplastic Disease Neoplasms by Histologic Type Immune System Diseases Gastrointestinal Agents Central Nervous System Depressants Antipsychotic Agents Pharmacologic Actions Adnexal Diseases Neoplasms Serotonin Agents Autonomic Agents Anti-Anxiety Agents Peripheral Nervous System Agents Neoplasms, Neuroepithelial |
