Study of Vioxx and Radiation Therapy for Brainstem Glioma

Condition(s) targeted: Glioma; Brain Neoplasms

Intervention: Vioxx (Drug)

Phase: Phase 1

Status: Terminated

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. Gender(s): Both.

Criteria:

Inclusion:

- 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:

- 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.

UTMDACC, Houston, Texas 77030, United States

Starting date: January 2002
Ending date: January 2004
Last updated: June 23, 2005