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| Sponsor: | Duke University |
|---|---|
| Collaborators: |
Eisai Inc. National Institute of Neurological Disorders and Stroke (NINDS) |
| Information provided by: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00636805 |
Purpose
Primary Objective:
Secondary Objective
| Condition | Intervention | Phase |
|---|---|---|
|
Brain Cancer |
Drug: Palonosetron (Aloxi) and Dexamethasone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | A Phase II Single Arm Trial of Palonesetron (PALO) for the Prevention of Acute and Delayed Chemotherapy Induced Nausea and Vomiting (CINV) in Malignant Glioma Patients Receiving Irinotecan in Combination With Bevacizumab |
| Estimated Enrollment: | 80 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Patient receives IV Aloxi
|
Drug: Palonosetron (Aloxi) and Dexamethasone
single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy.
Other Name: Aloxi
|
Before you receive the drug, you will have a physical exam and blood tests to determine you are able to take part. If you choose to participate in this study, you will sign a consent form. You will then get a medication called Palonosetron. Palonosetron will be given into a vein. This will take fifteen minutes. You will be given the Palonosetron and Dexamethasone 30 minutes before your first dose of Irinotecan and Bevacizumab chemotherapy. The total expected duration of your participation is 57 days. You will also be asked to complete 4 questionnaires asking questions about nausea and vomiting, your daily functioning and fatigue. You will be asked to complete these questionnaires before to starting your chemotherapy, the day you start your chemotherapy and for the next 4 days after receiving chemotherapy, for a total of 6 times. You will be asked to complete this set of questionnaires each of the 3 times that you receive chemotherapy during your 6-week treatment cycle.
The other treatments you would normally receive for your brain tumor and your routine care will not be affected by the study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
In order to be included in the study, patients must meet all of the following criteria:
Exclusion Criteria:
Patients are excluded from this study if they meet any of the following criteria:
Contacts and Locations| Contact: Leighann Bailey | 919-668-6230 | leighann.bailey@duke.edu |
| Contact: Waynette Freeman, RN | 919-684-3440 | Freem050@mc.duke.edu |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Principal Investigator: Mary Lou Affronti, RN, MSN, ANP, MHS | |
| Principal Investigator: | Mary Lou Affronti, RN, MSN, ANP, MHS | Duke University |
More Information
| Responsible Party: | Mary Lou Affronit, RN, MSN, ANP, MHS, Duke University Medical Center Preston Robert Tisch Brain Tumor Center |
| ClinicalTrials.gov Identifier: | NCT00636805 History of Changes |
| Other Study ID Numbers: | 00002273, P50 NS020023 |
| Study First Received: | February 27, 2008 |
| Last Updated: | May 4, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Aloxi Brain Neoplasm, Primary Brain Neoplasms, Malignant |
|
Brain Neoplasms Glioma Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate Irinotecan Bevacizumab BB 1101 Palonosetron Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents |