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NCT00900757 · ClinicalTrials.gov registry record · Phase 2
Intravenous Palonosetron With Radiotherapy and Concomitant Temozolomide
A Phase 2 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
NCT00900757 is a Phase 2 study that has completed, run by Duke University. The registered enrollment target is 57 participants.
The verdict
NCT00900757, a Phase 2 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
Study Summary
1\. Purpose and objective: 1. To determine the safety and tolerability of palonosetron in the prevention of radiation induced nausea and vomiting (RINV) in primary glioma patients receiving radiation (RT) and concomitant temozolomide (TMZ). 2. To determine the efficacy of palonosetron in primary glioma patients receiving six weeks of RT and concomitant TMZ 3. To evaluate the effect s of palonosetron on the quality of life of primary glioma patients receiving six weeks of RT and Concomitant TMZ. 2\. Study activities and Population group: We will conduct a phase II single arm trial of Palonosetron (PALO) for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ). All eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks. Forty subjects with gliomas will participate. 3\. Data analysis and risk/safety issues: The frequency of toxicity will be summarized by type and the most severe grade experienced. The complete response rate, defined as the proportion of patients with no emetic episode or use of rescue medication while receiving radiation and concomitant temozolomide, will be estimated with a 95% confidence interval.
Interventions
- DRUG Palonosetron (PALO)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2009-08 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00900757
The ClinicalTrials.gov registry entry for NCT00900757 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Palonosetron (PALO) is the first listed.
NCT00900757 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00900757 about?
NCT00900757 is a clinical study titled "Intravenous Palonosetron With Radiotherapy and Concomitant Temozolomide". 1\. Purpose and objective: 1. To determine the safety and tolerability of palonosetron in the prevention of radiation induced nausea and vomiting (RINV) in primary glioma patients receiving radiation (RT) and concomitant temozolomide (TMZ). 2. To determine the efficacy of palonosetron in primary gl...
What is the current status of trial NCT00900757?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2009-08. Estimated completion is 2012-12.
What interventions are being tested in trial NCT00900757?
The interventions under investigation include: Palonosetron (PALO) (DRUG).
Who is sponsoring clinical trial NCT00900757?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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