Clinical trial · Interventional
Study of Vioxx and Radiation Therapy for Brainstem Glioma
Phase I Study of Vioxx and Radiation Therapy for Brainstem Glioma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unavailability of study drug.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Neoplasms | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vioxx | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vioxx MTD
- interventionNames
- Drug: Vioxx
Primary outcomes (1)
- measure
- Maximum tolerated dose of VIOXX (rofecoxib) with 6 weeks of daily cranial radiation therapy
- timeFrame
- 1 month following radiation therapy
- description
- Maximum Tolerated Dose defined using each level's dose limiting toxicity (DLT) and continuous reassessment method (CRM).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available