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Study of Vioxx and Radiation Therapy for Brainstem Glioma
This study has been terminated.
Study NCT00038389   Information provided by M.D. Anderson Cancer Center
First Received: May 30, 2002   Last Updated: June 23, 2005   History of Changes

May 30, 2002
June 23, 2005
January 2002
 
To determine the maximum tolerated dose of VIOXX (rofecoxib) with 6 weeks of daily cranial radiation therapy.
Same as current
Complete list of historical versions of study NCT00038389 on ClinicalTrials.gov Archive Site
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.
Same as current
 
Study of Vioxx and Radiation Therapy for Brainstem Glioma
Phase I Study of Vioxx and Radiation Therapy for Brainstem Glioma

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 I
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
  • Glioma
  • Brain Neoplasms
Drug: Vioxx
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
30
January 2004
 

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.
Both
3 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00038389
 
ID01-460
M.D. Anderson Cancer Center
 
 
M.D. Anderson Cancer Center
June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP