Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038389
Status:
TERMINATED
Last Update Posted:
2018-11-01
First Post:
2002-05-30
Brief Title:
Study of Vioxx and Radiation Therapy for Brainstem Glioma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase I Study of Vioxx and Radiation Therapy for Brainstem Glioma
Status:
TERMINATED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unavailability of study drug
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
Rofecoxib is a non-steroidal anti-inflammatory drug
Patients in this study will take a certain amount of rofecoxib by mouth either once or twice a day during treatment with radiation therapy They will continue to take rofecoxib for 6 months after the end of radiation therapy Different dose levels will be given to different patients based on a statistical dose escalation increase program run on a computer called the Continuous Reassessment Method At least 3 patients will be treated on each dose level starting at the lowest level All patients are required to fill out a medication diary documenting the dose of rofecoxib they are taking and the time they take it
Patients will receive radiation therapy once a day five days a week for six weeks
During treatment patients will have a weekly exam including blood work and urine tests The blood work will include liver and kidney function tests as well as coagulation blood clotting tests
Patients will be taken off study if intolerable side effects occur including bleeding andor severe allergic response
During the 6 months after completion of radiation while patients are still receiving rofecoxib monthly medical histories physical exams blood tests and urine tests will be performed Patients will have a MRI at 1 3 and 6 months after completion of radiation therapy
The first year after completion of rofecoxib therapy patients will be interviewed and examined with blood and urine tests and MRI every 3 months During 1-3 years following completion of rofecoxib therapy this will be repeated every 6 months After 3 years following completion of rofecoxib follow-ups will occur yearly
This is an investigational study Rofecoxib is currently approved by the FDA for use in adults only A maximum of 30 patients will take part in this study at UTMDACC
Patients in this study will take a certain amount of rofecoxib by mouth either once or twice a day during treatment with radiation therapy They will continue to take rofecoxib for 6 months after the end of radiation therapy Different dose levels will be given to different patients based on a statistical dose escalation increase program run on a computer called the Continuous Reassessment Method At least 3 patients will be treated on each dose level starting at the lowest level All patients are required to fill out a medication diary documenting the dose of rofecoxib they are taking and the time they take it
Patients will receive radiation therapy once a day five days a week for six weeks
During treatment patients will have a weekly exam including blood work and urine tests The blood work will include liver and kidney function tests as well as coagulation blood clotting tests
Patients will be taken off study if intolerable side effects occur including bleeding andor severe allergic response
During the 6 months after completion of radiation while patients are still receiving rofecoxib monthly medical histories physical exams blood tests and urine tests will be performed Patients will have a MRI at 1 3 and 6 months after completion of radiation therapy
The first year after completion of rofecoxib therapy patients will be interviewed and examined with blood and urine tests and MRI every 3 months During 1-3 years following completion of rofecoxib therapy this will be repeated every 6 months After 3 years following completion of rofecoxib follow-ups will occur yearly
This is an investigational study Rofecoxib is currently approved by the FDA for use in adults only A maximum of 30 patients will take part in this study at UTMDACC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None