Phase I Study of Vioxx and Radiation Therapy for Brainstem Glioma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose of VIOXX (rofecoxib) with 6 weeks of daily cranial radiation therapy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Vioxx MTD
干预措施: Vioxx (Drug)
结局指标
主要结局
Maximum tolerated dose of VIOXX (rofecoxib) with 6 weeks of daily cranial radiation therapy
时间窗: 1 month following radiation therapy
Maximum Tolerated Dose defined using each level's dose limiting toxicity (DLT) and continuous reassessment method (CRM).
次要结局
未报告次要终点