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

NCT ID: NCT01370408

Last Updated: 2017-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2016-03-31

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

Conditions

Chemotherapy-induced Nausea and Vomiting

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Palonosetron

All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation

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

Group Type: EXPERIMENTAL

Palonosetron

Intervention Type: DRUG

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

ondansetron

Intervention Type: DRUG

Prior to IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV

Dexamethasone

Intervention Type: DRUG

Prior to IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV

Interventions

Palonosetron

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

Intervention Type: DRUG

ondansetron

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 Type: DRUG

Dexamethasone

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 Type: DRUG

Other Intervention Names

Aloxi; zofran; Dex

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Blood and Marrow Transplant Group of Georgia

OTHER

Sponsor Role: collaborator

Northside Hospital, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott R Solomon, MD

Role: PRINCIPAL_INVESTIGATOR

Blood and Marrow Transplant Group of Georgia

Locations

Northside Hospital

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

NSH 940

Identifier Type: -

Identifier Source: org_study_id