Clinical trial NCT01370408: Palonosetron, Ondansetron, and Dexamethasone for Delayed Nausea and Vomiting in Autologous Transplant Patients
Official title: A Unique Schedule of Palonosetron, Ondansetron, and Dexamethasone for the Prevention of Delayed Nausea and Vomiting in Patients Receiving Moderately Emetogenic Myeloablative Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chemotherapy-induced Nausea and Vomiting
Keywords: Autologous stem cell transplant
BEAM
Oral busulfan
Cyclophosphamide
Etoposide
Carboplatin
melphalan
Lead sponsor: Northside Hospital, Inc.
Sponsor class: OTHER
Collaborators: name: Blood and Marrow Transplant Group of Georgia
First posted: 2011-06-09
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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

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

Primary outcomes:
measure: Complete Response Rate for Delayed Chemotherapy Induced Nausea & Vomiting
timeFrame: 120 hours
Secondary outcomes:
measure: Complete Remission During Acute Phase Post-chemotherapy
timeFrame: 24 hours
measure: Complete Remission During Overall Chemotherapy Time Period
timeFrame: 120 hours
measure: Complete Control Rate for Nausea & Vomiting
timeFrame: 120 hours
measure: Emetic Episodes
timeFrame: 120 Hours
measure: Patients Who Experience First Emetic Episode Within 24 Hours
timeFrame: 24 hours
measure: Number of Patients That Required First Administration of Rescue Medication Within 24 Hours
timeFrame: 24 hours
measure: Number of Patients That Experience Treatment Failure Within the First 24 Hours
timeFrame: 24 hours
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
Study officials:
affiliation: Blood and Marrow Transplant Group of Georgia
name: Scott R Solomon, MD
role: PRINCIPAL_INVESTIGATOR
References: