Phase I Study of Vioxx and Radiation Therapy for Brainstem Glioma
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
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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of VIOXX (rofecoxib) with 6 weeks of daily cranial radiation therapy
Maximum Tolerated Dose defined using each level's dose limiting toxicity (DLT) and continuous reasssessment method (CRM).
1 month following radiation therapy
Eric L. Chang, MD
UT MD Anderson Cancer Center
United States: Food and Drug Administration
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