Atlanta, Georgia 30342


Purpose:

In order to decrease this delayed CINV, the investigators have developed a unique schedule of antiemetics that takes advantage of palonosetron's long elimination half-life (40 hours). 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. The investigators hypothesize that this antiemetic schedule will significantly reduce the delayed CINV compared to historical controls


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


NCT ID:

NCT01370408


Primary Contact:

Principal Investigator
Scott R Solomon, MD
Blood and Marrow Transplant Group of Georgia

Stacey Brown, BA
Phone: 404-851-8238
Email: stacey.brown@Northside.com


Backup Contact:

Email: justin.laporte@northside.com
Justin Laporte, PharmD
Phone: 404-255-1930


Location Contact:

Atlanta, Georgia 30342
United States

Stacey Brown, BA
Phone: 404-851-8238
Email: stacey.brown@northside.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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