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

NCT01370408 | Completed Phase 2 Results

• 1 other identifier: NSH 940
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Nausea and Vomiting

Keywords

Autologous stem cell transplant; BEAM; Oral busulfan; Cyclophosphamide; Etoposide; Carboplatin; melphalan

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate for Delayed Chemotherapy Induced Nausea & Vomiting

  Proportion of patients achieving a delayed CINV complete response (CR) defined as no emetic episode and no use of rescue medications during the 24-120 hour period post chemotherapy.

  120 hours

Secondary Outcomes (7)

• Complete Remission During Acute Phase Post-chemotherapy

  24 hours

• Complete Remission During Overall Chemotherapy Time Period

  120 hours

• Complete Control Rate for Nausea & Vomiting

  120 hours

• Emetic Episodes

  120 Hours

• Patients Who Experience First Emetic Episode Within 24 Hours

  24 hours

Study Arms (1)

Palonosetron

EXPERIMENTAL

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

Drug: Palonosetron; Drug: ondansetron; Drug: Dexamethasone

Interventions

Palonosetron 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

Also known as: Aloxi

Palonosetron

ondansetron 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

Also known as: zofran

Palonosetron

Dexamethasone 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

Also known as: Dex

Palonosetron

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northside Hospital, Inc.: lead
• Blood and Marrow Transplant Group of Georgia: collaborator

Study Sites (1)

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

MeSH Terms

Conditions

Vomiting

Interventions

Palonosetron; Ondansetron; Dexamethasone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr. Scott Solomon
• Organization: Blood and Marrow Transplant Group of Georgia

ssolomon@bmtga.com

404-255-1930

Study Officials

• Scott R Solomon, MD

  Blood and Marrow Transplant Group of Georgia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: June 9, 2011
• Study Start: February 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 17, 2017
• Results First Posted: February 6, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)