Study of Vioxx and Radiation Therapy for Brainstem Glioma
Information source: M.D. Anderson Cancer Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glioma; Brain Neoplasms
Intervention: Vioxx (Drug)
Phase: Phase 1
Sponsored by: M.D. Anderson Cancer Center
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.
Official title: Phase I Study of Vioxx and Radiation Therapy for Brainstem Glioma
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To determine the maximum tolerated dose of VIOXX (rofecoxib) with 6 weeks of daily cranial radiation therapy.
Secondary outcome: To determine the safety, spectrum, and severity of toxicities and reversible toxicity of rofecoxib and cranial radiation in previously untreated patients with diffuse pontine gliomas.
Minimum age: 3 Years.
Maximum age: 85 Years.
- 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
- 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.
- 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.
Locations and Contacts
UTMDACC, Houston, Texas 77030, United States
Starting date: January 2002
Ending date: January 2004
Last updated: June 23, 2005