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| Sponsor: | Duke University |
|---|---|
| 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: | Supportive Care, Open Label, Single Group Assignment, Safety/Efficacy Study |
| 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: | October 2008 |
| Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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.
|
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: Alise Brickhouse, BA | 919-684-3107 | Alise.Brickhouse@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: Lee Jones, PhD | |
| Principal Investigator: | Lee Jones, PhD | Duke University |
More Information
| Responsible Party: | Duke University Medical Center Preston Robert Tisch Brain Tumor Center ( Lee Jones, PhD ) |
| Study ID Numbers: | 00002273 |
| Study First Received: | February 27, 2008 |
| Last Updated: | November 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00636805 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Aloxi Brain Neoplasm, Primary Brain Neoplasms, Malignant |
|
Anti-Inflammatory Agents Dexamethasone Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Irinotecan Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Central Nervous System Neoplasms Bevacizumab Brain Diseases Hormones Serotonin Antagonists |
Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Growth Inhibitors Angiogenesis Modulating Agents Glioma Nervous System Neoplasms Dexamethasone acetate Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Growth Substances Nervous System Diseases Gastrointestinal Agents Central Nervous System Diseases Enzyme Inhibitors |