Phase II Clinical and Pharmacologic Study of Radiation Therapy and CAI (Carboxy-Amido Triazole) in Adults With Newly Diagnosed Glioblastoma Multiforme
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 8
- 主要终点
- Correlation Between PK CAI and Toxicity in This pt Population
研究概览
简要总结
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Phase II trial to study the effectiveness of carboxyamidotriazole plus radiation therapy in treating patients who have newly diagnosed supratentorial glioblastoma multiforme.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate overall survival rate in patients administered CAI (carboxyamidotriazole) and radiation therapy to adults with newly diagnosed glioblastoma multiforme.
II. To determine the toxicity of CAI when combined with cranial irradiation. III. To estimate correlations between pharmacokinetic parameters, including steady state CAI concentration, with toxicity and/or drug activity in this patient population.
IV. To estimate duration of disease free progression with this treatment regime.
OUTLINE: This is a multicenter study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme)
- •Patients must have measurable or non-measurable tumor on the post operative, pretreatment MRI/CT scan (within two weeks of starting treatment)
- •Patients must not have received prior radiation therapy, chemotherapy, hormonal therapy, immunotherapy or therapy with biologic agents (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK or gene therapy), or hormonal therapy for their brain tumor; glucocorticoid therapy is allowed
- •Patients must have recovered from the immediate post-operative period and be maintained on a stable steroid regimen (no increase for the last five days)
- •Absolute neutrophil count >= 1500/mm^3
- •Platelets >= 100,000/mm^3
- •Hemoglobin concentration >= 9.0 g/dl
- •Creatinine =< 1.7mg/dL
- •Total bilirubin =< 1.2 mg/dl
- •Transaminases =< 2 times above the upper limits of the institutional normal
- •Estimated life expectancy greater than 2 months
- •Patients must give informed consent and understand the investigational nature of this study and its potential risks and benefits
- •Patients, if female and of childbearing potential must have a negative serum beta-hCG test and must not be breast feeding; all patients with the potential for pregnancy should be counseled and requested to follow acceptable birth control methods to avoid conception
- •Patients must have a Karnofsky performance status of >= 60%
- •No other serious concurrent infection or other medical illness should be present which would jeopardize the ability of the patient to receive the drug outlined in this protocol with reasonable safety
- •Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ; patients with prior malignancies must be disease-free for >= five years
排除标准
- •Patients must be able to comply with prescribed medical care
- •Prior therapy for the brain tumor (except surgery)
- •Prior treatment with antineoplastic agents, including CAI
研究组 & 干预措施
Treatment (RT and CAI)
Patients receive induction therapy consisting of radiotherapy once daily 5 days a week plus oral carboxyamidotriazole once daily for 6 weeks followed by carboxyamidotriazole alone daily for 4 weeks. Patients continue on oral carboxyamidotriazole once daily as maintenance therapy in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for survival.
Other: pharmacological study, radiation therapy
干预措施: radiation therapy (Radiation)
Treatment (RT and CAI)
Patients receive induction therapy consisting of radiotherapy once daily 5 days a week plus oral carboxyamidotriazole once daily for 6 weeks followed by carboxyamidotriazole alone daily for 4 weeks. Patients continue on oral carboxyamidotriazole once daily as maintenance therapy in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for survival.
Other: pharmacological study, radiation therapy
干预措施: carboxyamidotriazole (Drug)
Treatment (RT and CAI)
Patients receive induction therapy consisting of radiotherapy once daily 5 days a week plus oral carboxyamidotriazole once daily for 6 weeks followed by carboxyamidotriazole alone daily for 4 weeks. Patients continue on oral carboxyamidotriazole once daily as maintenance therapy in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for survival.
Other: pharmacological study, radiation therapy
干预措施: pharmacological study (Other)
结局指标
主要结局
Correlation Between PK CAI and Toxicity in This pt Population
时间窗: during treatment
PK paramenters including steady state CAI concentrations with toxicity/or drug activity
Overall Survival Rate
时间窗: approximately 30 months
estimated period of time event assessed 30 months. event assessed from time of histological diagnosis to death
Toxicity of CAI When Combined With RT
时间窗: pts were reviewed for toxicity while on treatement - median time of 2 months
patients who experienced a grade 3 or higher event considered at least possibly related to CAI
次要结局
未报告次要终点