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| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 30, 2002 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | January 2002 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE |
To determine the maximum tolerated dose of VIOXX (rofecoxib) with 6 weeks of daily cranial radiation therapy. |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00038389 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
To determine the safety, spectrum, and severity of toxicities and reversible toxicity of rofecoxib and cranial radiation in previously untreated patients with diffuse pontine gliomas. |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Descriptive Information | |
| Brief Title ICMJE | Study of Vioxx and Radiation Therapy for Brainstem Glioma |
| Official Title ICMJE | Phase I Study of Vioxx and Radiation Therapy for Brainstem Glioma |
| Brief Summary | It is of interest to determine whether COX-2 inhibitors given with radiation therapy can prolong the progression-free survival in brain stem glioma. Diffuse pontine brainstem gliomas are more common in children, but are also seen in adults. However, the use of commercially available COX-2 inhibitors has not been evaluated in the pediatric population and the proper dosing in pediatrics is unknown. Therefore a Phase I study will need to be conducted as a first step. Rofecoxib is an FDA approved COX-2 inhibitor for use in adults. This phase I study is designed to determine the maximum tolerated dose of Rofecoxib given concurrently with standard radiation therapy for diffuse pontine brainstem glioma. |
| Detailed Description | |
| Study Phase | Phase I |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| Condition ICMJE |
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| Intervention ICMJE | Drug: Vioxx |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Terminated |
| Enrollment ICMJE | 30 |
| Completion Date | January 2004 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion:
Exclusion:
|
| Gender | Both |
| Ages | 3 Years to 85 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00038389 |
| Responsible Party | |
| Study ID Numbers ICMJE | ID01-460 |
| Study Sponsor ICMJE | M.D. Anderson Cancer Center |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | M.D. Anderson Cancer Center |
| Verification Date | June 2005 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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