Palonosetron, Ondansetron, and Dexamethasone for Delayed Nausea and Vomiting in Autologous Transplant Patients

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northside Hospital, Inc.
• Collaborator: Blood and Marrow Transplant Group of Georgia
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Ondansetron; Palonosetron

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