Study of Vioxx and Radiation Therapy for Brainstem Glioma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00038389|
Recruitment Status : Terminated (Unavailability of study drug.)
First Posted : May 31, 2002
Last Update Posted : July 31, 2012
|Condition or disease||Intervention/treatment||Phase|
|Glioma Brain Neoplasms||Drug: Vioxx||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Vioxx and Radiation Therapy for Brainstem Glioma|
|Study Start Date :||January 2002|
|Actual Primary Completion Date :||October 2004|
|Actual Study Completion Date :||January 2005|
|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
- Maximum tolerated dose of VIOXX (rofecoxib) with 6 weeks of daily cranial radiation therapy [ Time Frame: 1 month following radiation therapy ]Maximum Tolerated Dose defined using each level's dose limiting toxicity (DLT) and continuous reasssessment method (CRM).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00038389
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Eric L. Chang, MD||UT MD Anderson Cancer Center|