Study of Vioxx and Radiation Therapy for Brainstem Glioma
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Vioxx and Radiation Therapy for Brainstem Glioma|
- Maximum tolerated dose of VIOXX (rofecoxib) with 6 weeks of daily cranial radiation therapy [ Time Frame: 1 month following radiation therapy ] [ Designated as safety issue: Yes ]Maximum Tolerated Dose defined using each level's dose limiting toxicity (DLT) and continuous reasssessment method (CRM).
|Study Start Date:||January 2002|
|Study Completion Date:||January 2005|
|Primary Completion Date:||October 2004 (Final data collection date for primary outcome measure)|
|Experimental: Vioxx MTD||
Starting dose for patients age 3-14 years 10.0 mg/1.73 m2 and for patients above 14 years of age 12.5 mg for 5 days per week for 6 weeks during radiation treatment, and 7 days per week for 6 months after radiation treatment.
Other Name: Rofecoxib
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 and/or 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.
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Eric L. Chang, MD||UT MD Anderson Cancer Center|