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Phase I Study of Vioxx and Radiation Therapy for Brainstem Glioma

Phase 1
3 Years
85 Years
Not Enrolling
Glioma, Brain Neoplasms

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Trial Information

Phase I Study of Vioxx and Radiation Therapy for Brainstem Glioma

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

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.

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of VIOXX (rofecoxib) with 6 weeks of daily cranial radiation therapy

Outcome Description:

Maximum Tolerated Dose defined using each level's dose limiting toxicity (DLT) and continuous reasssessment method (CRM).

Outcome Time Frame:

1 month following radiation therapy

Safety Issue:


Principal Investigator

Eric L. Chang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2002

Completion Date:

January 2005

Related Keywords:

  • Glioma
  • Brain Neoplasms
  • Brain Stem Tumor
  • Brain Neoplasms
  • Neoplasms
  • Glioma



UT MD Anderson Cancer Center Houston, Texas  77030