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Study of Vioxx and Radiation Therapy for Brainstem Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00038389
Recruitment Status : Terminated (Unavailability of study drug.)
First Posted : May 31, 2002
Last Update Posted : November 1, 2018
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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 or disease Intervention/treatment Phase
Glioma Brain Neoplasms Drug: Vioxx Phase 1

Detailed Description:

Rofecoxib is a non-steroidal anti-inflammatory drug.

Patients in this study will take a certain amount of rofecoxib by mouth either once or twice a day during treatment with radiation therapy. They will continue to take rofecoxib for 6 months after the end of radiation therapy. Different dose levels will be given to different patients based on a statistical dose escalation (increase) program run on a computer called the Continuous Reassessment Method. At least 3 patients will be treated on each dose level starting at the lowest level. All patients are required to fill out a medication diary, documenting the dose of rofecoxib they are taking and the time they take it.

Patients will receive radiation therapy once a day, five days a week for six weeks.

During treatment, patients will have a weekly exam, including blood work and urine tests. The blood work will include liver and kidney function tests as well as coagulation (blood clotting) tests.

Patients will be taken off study if intolerable side effects occur, including bleeding and/or severe allergic response.

During the 6 months after completion of radiation, while patients are still receiving rofecoxib, monthly medical histories, physical exams, blood tests, and urine tests will be performed. Patients will have a MRI at 1, 3, and 6 months after completion of radiation therapy.

The first year after completion of rofecoxib therapy, patients will be interviewed and examined with blood and urine tests and MRI every 3 months. During 1-3 years following completion of rofecoxib therapy, this will be repeated every 6 months. After 3 years following completion of rofecoxib, follow-ups will occur yearly.

This is an investigational study. Rofecoxib is currently approved by the FDA for use in adults only. A maximum of 30 patients will take part in this study at UTMDACC.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Vioxx and Radiation Therapy for Brainstem Glioma
Study Start Date : October 2001
Actual Primary Completion Date : October 2004
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Vioxx MTD Drug: Vioxx
Starting dose for patients age 3-14 years 10.0 mg/1.73 m2 and for patients above 14 years of age 12.5 mg for 5 days per week for 6 weeks during radiation treatment, and 7 days per week for 6 months after radiation treatment.
Other Name: Rofecoxib

Primary Outcome Measures :
  1. Maximum tolerated dose of VIOXX (rofecoxib) with 6 weeks of daily cranial radiation therapy [ Time Frame: 1 month following radiation therapy ]
    Maximum Tolerated Dose defined using each level's dose limiting toxicity (DLT) and continuous reassessment method (CRM).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   3 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00038389

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United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Principal Investigator: Eric L. Chang, MD UT MD Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00038389    
Other Study ID Numbers: ID01-460
First Posted: May 31, 2002    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Keywords provided by M.D. Anderson Cancer Center:
Brain Stem Tumor
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents