NCT00071539已完成2 期
Safety and Efficacy Study to Treat Recurrent Grade 4 Malignant Brain Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 主要终点
- Survival
研究概览
简要总结
Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be effective in treating malignant glioma.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients fulfilling any of the following criteria should not be enrolled in the study:
- •Previous myelosuppressive chemotherapy within the past 4 weeks of the start of the infusion. Patients who have received more than two chemotherapy regimens (single therapy or combination therapy) are ineligible.
- •Any form of brain radiation within 10 weeks of the start of the infusion.
- •Previous gamma knife radiosurgery, stereotactic radiosurgery, and/or internal radiotherapy, unless the recurrence/progression is histologically confirmed (fine-needle biopsy).
- •Prior intracavitary biologic response modifiers or monoclonal antibodies.
- •Uncontrolled seizures.
- •Bilateral or multifocal tumors.
- •Evidence of cerebral uncal herniation.
- •Midline brain shift on MRI scan of > 0.5 cm prior to resection; patients with subfalcine herniation may be enrolled.
- •Tumors involving the brainstem or cerebellum.
- •Diffuse subependymal or CSF disease.
- •Women who are pregnant or breast feeding. All women of child-bearing potential should be excluded unless they have a negative pregnancy test and are using adequate contraceptive measures or are surgically sterile. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing.
- •Fertile males not practicing adequate contraception and whose female partners are not using adequate contraceptive protection.
- •Prior or concurrent investigational treatment within 30 days of study entry.
- •Active infection requiring treatment or having an unexplained febrile illness.
- •Systemic diseases or other conditions which may be associated with unacceptable anesthetic/operative risk and/or which would not allow safe completion of this study protocol.
- •Prior or concurrent malignancy (curatively treated carcinoma-in-situ or basal cell carcinoma or patients who have been disease free for at least 5 years are eligible).
研究组 & 干预措施
TP38 50 ng/mL
Experimental
干预措施: TP-38 (Drug)
TP38 100 ng/mL
Experimental
干预措施: TP38 (Drug)
结局指标
主要结局
Survival
时间窗: 28 weeks
% patients alive
次要结局
- Time to progression (TTP)(28 weeks)
研究者
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