ACTRN12609000736246撤回1 期
Phase I trial of dendritic cell vaccination and celecoxib with postoperative radiotherapy and temozolomide for treatment of malignant glioma.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1. Malignant glioma (World Health Organisation grade IV). Preoperative assessment by clinical presentation and Computed tomography (CT) / Magnetic Resonance Imaging (MRI) scans appearance of the lesion will identify suitable candidates. Progression to enrolment will be dependent upon the neuropathological diagnosis being confirmed.
- •2. Age 18 – 75
- •3. Macroscopic tumour resection (ie it was felt by the surgeon at operation that all visible tumour was resected; tumour seen on postoperative imaging does not exclude the patient from consideration)
- •4. Patient undergoing standard postoperative radiotherapy and concurrent temozolomide chemotherapy, followed by post-radiotherapy temozolomide.
排除标准
- •1. Presence of extensive intracranial or intraspinal disease which precludes total macroscopic or subtotal resection.
- •2. Eastern Cooperative Oncology Group (ECOG) status > 2
- •3. Documented history of auto-immune disease such as systemic lupus erythematosus (SLE), sarcoidosis, rheumatoid arthritis, glomerulonephritis or vasculitis. Previous use of long term immunosuppressive therapy in recent months. (NB perioperative short term
- •dexamethasone, which is normal treatment, does not preclude inclusion in the trial)
- •4. Prior use of any immunotherapeutic agent.
- •5. Serology indicating active infection with Hepatitis B or C, human immunodeficiency virus (HIV), human T-cell leukemia virus-1 (HTLV-1) or syphilis
- •6. Significant non-malignant disease (eg severe cardiac or respiratory dysfunction)
- •7. Pregnancy
- •8. Presence of another malignancy.
- •9. Clinically relevant abnormal haematological and biochemical parameters (as assessed by the treating clinician).
- •10. History of significant cardiac history (ie myocardial infarction < 1year, unstable angina).
- •11. Severe asthma or previous reactions to any non-steroidal anti-inflammatory medication.
- •12. If the patient is taking regular medications known to interact with celecoxib (lithium, warfarin, other Non-steroidal anti-inflammatory drugs).
- •13. Inadequate venous access for leukapheresis.
研究者
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