Study of Vioxx and Radiation Therapy for Brainstem Glioma - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00038389

Purpose

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

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer Childhood Brain Tumors Radiation Therapy

Drug Information available for: Rofecoxib

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To determine the maximum tolerated dose of VIOXX (rofecoxib) with 6 weeks of daily cranial radiation therapy.

Secondary Outcome Measures:

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.

Estimated Enrollment:	30
Study Start Date:	January 2002
Estimated Study Completion Date:	January 2004

Eligibility

Ages Eligible for Study:	3 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038389

Locations

United States, Texas
UTMDACC
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

More Information

No publications provided

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

Keywords provided by M.D. Anderson Cancer Center:

Brain Stem Tumor

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on July 02, 2009