Study of Vioxx and Radiation Therapy for Brainstem Glioma

• Status: Terminated
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Rofecoxib

Criteria

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.