Study of Vioxx and Radiation Therapy for Brainstem Glioma
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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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of Vioxx and Radiation Therapy for Brainstem Glioma |
- Maximum tolerated dose of VIOXX (rofecoxib) with 6 weeks of daily cranial radiation therapy [ Time Frame: 1 month following radiation therapy ] [ Designated as safety issue: Yes ]Maximum Tolerated Dose defined using each level's dose limiting toxicity (DLT) and continuous reasssessment method (CRM).
| Enrollment: | 8 |
| Study Start Date: | January 2002 |
| Study Completion Date: | January 2005 |
| Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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.
Eligibility| Ages Eligible for Study: | 3 Years to 85 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Eric L. Chang, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00038389 History of Changes |
| Other Study ID Numbers: | ID01-460 |
| Study First Received: | May 30, 2002 |
| Last Updated: | July 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Brain Stem Tumor |
Additional relevant MeSH terms:
|
Brain Neoplasms Neoplasms Glioma Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Rofecoxib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013