Study of Vioxx and Radiation Therapy for Brainstem Glioma
Stopped early · Phase 1
Conditions studied: Glioma, Brain Neoplasms
In brief
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.
Key facts
- Study ID
- NCT00038389
- Run by
- M.D. Anderson Cancer Center
- People needed
- 8
- Starts
- 2001-10-01
- Expected to finish
- 2005-01-01
- Last updated by the study team
- 2018-11-01
Who can join
Age: 3 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Newly diagnosed infiltrating lesion involving the pons and an MRI pattern of diffuse infiltration, that is not focal. The tumor may extend beyond the boundary of the pons.
- MRI of the brain with or without gadolinium within 4 weeks of starting therapy.
- Clinical history < 6 months duration
- Children >3 years of age and adults >18 years of age
- Treatment to begin within 6 weeks of diagnosis.
- Written informed consent
- Performance status: ECOG 0,1,2 or equivalent Lansky Play Performance Scale.
- All patients must have adequate bone marrow function (ANC>1000, platelets >100,000, SGPT < 2.5x ULN) and renal function (creatinine clearance >50/ml/min/1.73 m2 or age-adjusted serum creatinine < 3x ULN)
- MRI of the spine within 4 weeks of starting therapy.
You may not qualify if…
- Pregnancy. All participants who are of child-bearing age must agree to use a method of birth control/pregnancy prevention.
- Bilirubin > 3x ULN.
- History of gastrointestinal bleeding.
- History of GI perforation due to ulcerative disease.
- Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
- Prior therapy (Dexamethasone is not considered therapy.)
- Prior malignancy
- Metastasis to the spine.
Where it is running
- UT MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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