NCT02496988尚未招募4 期
A Study of CIK in Combination With Temozolomide With and Without Radiation in Adults With Advanced Malignant Gliomas
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this study is to determine whether combining of Temozolomide and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with Advanced Malignant Gliomas. The effectiveness and safety of CIK cells for the treatment of Malignant Glioma is also evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with documented histologically confirmed primary grade 4 advanced malignant glioma.
- •No more than 3 prior relapses or prior systemic treatments.
- •Recurrent disease documented by MRI after prior therapy.
- •Must have at least one site of bidimensionally measurable disease:
- •archived tissue from the initial diagnosis of advanced malignant glioma or upon transformation to advanced malignant glioma are available for central review within approximately 4 weeks after enrollment.
- •Completed at least one full cycle of temozolomide of 200 mg/m2/day administered on Days 1-5 of a 28-day cycle, without unacceptable toxicity or progression.
- •Karnofsky performance status of 60 or more. Adequate organ and bone marrow function as defined by hematological and serum chemistry limits.
- •At least 18 years old.
- •Both men and women must practice adequate contraception.
- •Informed consent.
排除标准
- •Progressed while on temozolomide.
- •Evidence of acute intracranial or intratumoral hemorrhage > Grade
- •Not recovered from the toxic effects of prior therapy.
- •Pregnant or breast feeding.
- •History of diabetes mellitus.
- •Uncontrolled intercurrent illness.
- •Congestive heart failure, unstable angina, or a myocardial infarction within 3 months of entering the study.
- •HIV positive.
- •Diagnosis of another malignancy may exclude subject from study.
研究组 & 干预措施
Temozolomide
Other
Capsules supplied in 5-mg, 20-mg, 100-mg, 140-mg, 180-mg, and 250-mg strengths; dosed at 200 mg/m2/day for 5 consecutive days, repeated every 28 days
干预措施: Temozolomide (Drug)
Temozolomide+CIK
Other
Autologous cytokine-induced killer cells were transfer via venous one week after Temozolomide treat
干预措施: CIK (Biological)
结局指标
主要结局
Overall survival
时间窗: 5 years
次要结局
- Adverse events(4 weeks)
研究者
相似试验
尚未招募
1 期
Effect of Cytokine-induced Killer Cells for Stage I-II Malignant GliomasCytokine-Induced Killer CellsMilignant GliomasNCT02494804The First People's Hospital of Changzhou80
已完成
1 期
Temsirolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma MultiformeAdult Giant Cell GlioblastomaAdult GlioblastomaAdult GliosarcomaNCT00316849National Cancer Institute (NCI)56
已完成
2 期
Studies of Temozolomide in Combination With Topotecan in Refractory and Relapsed Paediatric Solid TumoursBrain TumorsSolid TumorsNeuroblastomaNCT00918320Gustave Roussy, Cancer Campus, Grand Paris129
已完成
2 期
Ipilimumab + Temozolomide in Metastatic MelanomaMetastatic MelanomaNCT01119508M.D. Anderson Cancer Center64
已完成
2 期
Phase II Cisplatin + Temozolomide in Malignant Glial Tumours in Children and AdolescentsGliomaNCT00147160Gustave Roussy, Cancer Campus, Grand Paris87