Palonosetron, Ondansetron, and Dexamethasone for Delayed Nausea and Vomiting in Autologous Transplant Patients
Condition: Chemotherapy-induced Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Intervention: Palonosetron; ondansetron; Dexamethasone
Intervention description: Prior to IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO; Prior to IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV; Prior to IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV
Intervention MeSH terms: Dexamethasone; Ondansetron; Palonosetron
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 85.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Autologous stem cell transplant; BEAM; Oral busulfan; Cyclophosphamide; Etoposide; Carboplatin; melphalan

Summary:

      In this study, patients will receive ondansetron 8mg and dexamethasone 10mg intravenously 30
      minutes prior to myeloablative preparative chemotherapy until the last day of chemotherapy.
      On the final day of chemotherapy, palonosetron 0.25mg and dexamethasone 10mg will be
      administered intravenously 30 minutes prior to the chemotherapy. If the chemotherapy regimen
      is only 1 day of the chemotherapy then only palonosetron and dexamethasone will be
      administered 30 minutes prior to chemotherapy. Dexamethasone 8mg once daily will be given
      orally for 2 days following chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  candidate for high-dose chemotherapy and autologous hematopoietic stem cell
             transplantation

          -  Karnofsky performance status >/= 60%

          -  scheduled to receive one of the following conditioning regimens

          -  BEAM

          -  Oral Busulfan/cyclophosphamide with or without etoposide

          -  Carboplatin/Etoposide

          -  Melphalan

          -  Negative pregnancy test

          -  Must be able to complete a daily nausea/vomiting questionnaire and Quality of Life

        Exclusion Criteria:

          -  Active infection requiring IV antibiotics

          -  Known active hepatitis B and/or hepatitis C or HIV infection

          -  prior non-hematological malignancies at other sites except surgically treated
             non-melanoma skin cancer, superficial cervical cancer or other cancer from which the
             patient had been disease free for >/= 5 years

          -  Uncontrolled medical problems including any of the following

          -  Diabetes mellitus

          -  Cardiac, pulmonary, hepatic or renal disease

          -  myocardial infarction within the past 6 months

          -  Morbid obesity (BMT >40)

          -  History of CNS metastases, psychiatric or CNS disorders interfering with the ability
             to comply with the study

          -  Known hypersensitivity to 5-HT3 antagonists, dexamethasone and/or their components

          -  Intrathecal therapy within 24 hours before starting preparative regimen

          -  Receiving any antiemetic therapy 24 hours before starting preparative regimen

          -  Any 5-HT3 antagonist used as a rescue medication