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

Information source: Northside Hospital, Inc.
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chemotherapy-induced Nausea and Vomiting

Intervention: Palonosetron, ondansetron, dexamethasone (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Northside Hospital, Inc.

Official(s) and/or principal investigator(s):
Scott R Solomon, MD, Principal Investigator, Affiliation: Blood and Marrow Transplant Group of Georgia

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

Summary

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

Clinical Details

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 design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Complete Response Rate for delayed chemotherapy induced nauseas & vomiting

Secondary outcome:

Complete remission during acute phase post-chemotherapy

Complete remission during overall chemotherapy time period

Complete control rate for nausea & vomiting

Emetic episodes

First emetic episode

First administration of rescue medication

Treatment failure

Severity of nausea

Quality of life (QOL)

Eligibility

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

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

Locations and Contacts

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

Northside Hospital, Atlanta, Georgia 30342, United States; Recruiting
Stacey Brown, BA, Phone: 404-851-8238, Email: stacey.brown@northside.com
Justin Laporte, PharmD, Phone: 404-255-1930, Email: justin.laporte@northside.com
H. Kent Holland, MD, Sub-Investigator
Asad Bashey, MD, Sub-Investigator
Lawrence E Morris, MD, Sub-Investigator
Justin Laporte, PharmD, Sub-Investigator
Additional Information

Starting date: February 2012
Last updated: October 10, 2014

Page last updated: November 27, 2014

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