Palonosetron, Ondansetron, and Dexamethasone for Delayed Nausea and Vomiting in Autologous Transplant Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 4/21/2016 |
| Start Date: | February 2012 |
| End Date: | June 2016 |
| Contact: | Stacey Brown, BA |
| Email: | stacey.brown@Northside.com |
| Phone: | 404-851-8238 |
A Unique Schedule of Palonosetron, Ondansetron, and Dexamethasone for the Prevention of Delayed Nausea and Vomiting in Patients Receiving Moderately Emetogenic Myeloablative Chemotherapy
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
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
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
We found this trial at
1
site
1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
Atlanta, Georgia 30342
(404) 851-8000
Phone: 404-851-8238
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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