Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
M.D. Anderson Cancer Center |
---|---|
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00038389 |
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.
Condition | Intervention | Phase |
---|---|---|
Glioma Brain Neoplasms |
Drug: Vioxx |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase I Study of Vioxx and Radiation Therapy for Brainstem Glioma |
Estimated Enrollment: | 30 |
Study Start Date: | January 2002 |
Estimated Study Completion Date: | January 2004 |
Ages Eligible for Study: | 3 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion:
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)
Exclusion:
Prior malignancy
Study ID Numbers: | ID01-460 |
Study First Received: | May 30, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00038389 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Brain Stem Tumor |
Anti-Inflammatory Agents Cyclooxygenase Inhibitors Brain Stem Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Cyclooxygenase 2 Inhibitors Brain Neoplasms Neuroectodermal Tumors Analgesics, Non-Narcotic |
Neoplasms, Germ Cell and Embryonal Rofecoxib Neuroepithelioma Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Glioma Antirheumatic Agents Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Neoplasms, Nerve Tissue Central Nervous System Neoplasms Brain Diseases Cyclooxygenase 2 Inhibitors Neoplasms by Site Sensory System Agents Therapeutic Uses Neoplasms, Germ Cell and Embryonal Anti-Inflammatory Agents, Non-Steroidal Glioma Analgesics Nervous System Neoplasms |
Neoplasms by Histologic Type Nervous System Diseases Cyclooxygenase Inhibitors Central Nervous System Diseases Enzyme Inhibitors Pharmacologic Actions Neuroectodermal Tumors Brain Neoplasms Neoplasms Analgesics, Non-Narcotic Rofecoxib Peripheral Nervous System Agents Antirheumatic Agents Neoplasms, Neuroepithelial Central Nervous System Agents |