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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.
 
ClinicalTrials.gov Identifier: NCT00038389
Recruitment Status : Terminated (Unavailability of study drug.)
First Posted : May 31, 2002
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE May 30, 2002
First Posted Date  ICMJE May 31, 2002
Last Update Posted Date November 1, 2018
Study Start Date  ICMJE October 2001
Actual Primary Completion Date October 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2018)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
To determine the maximum tolerated dose of VIOXX (rofecoxib) with 6 weeks of daily cranial radiation therapy.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Vioxx and Radiation Therapy for Brainstem Glioma
Official Title  ICMJE Phase I Study of Vioxx and Radiation Therapy for Brainstem Glioma
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Glioma
  • Brain Neoplasms
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Vioxx MTD
Intervention: Drug: Vioxx
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 21, 2010)
8
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
30
Actual Study Completion Date  ICMJE January 2005
Actual Primary Completion Date October 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 85 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00038389
Other Study ID Numbers  ICMJE ID01-460
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric L. Chang, MD UT MD Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date October 2018

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