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Home > "P" Clinical Trials Conditions > Phase I Study of Vioxx and Radiation Therapy for Brainstem Glioma  Phase I Study of Vioxx and Radiation Therapy for Brainstem Glioma
Phase I Study of Vioxx and Radiation Therapy for Brainstem Glioma
For Condition: Glioma,Brain Neoplasms
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 3 Years/85 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 30
Location and Contact Information:
UTMDACC *Recruiting*
Houston, Texas, 77030
United States
Recruiting Eric Chang 713-563-2336
Additional Information:
Study ID Numbers: ID01-460;
Study Start Date: January 2002
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038389
Other Glioma Studies:
1. Natural History of Patients with Brain and Spinal Cord Tumors
2. A Phase I Study of SU101 in Pediatric Patients with Refractory Malignancy
3. STI571 to Treat Malignant Brain Tumors
4. A Phase II Study of Pegylated Interferon Alfa 2b (PEG-Intron™ (Trademark)) in Children with Diffuse Pontine Gliomas
5. Phase II Trial of Peginterferon alpha-2b and Thalidomide in Adults with Recurrent Gliomas
Related Studies:
Other Glioma Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Phase I Study of Vioxx and Radiation Therapy for Brainstem Glioma
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