jRCT2031190074已完成不适用
Anti-PD-1 antibody therapy for recurrent / progressive Meningioma: an investigator-initiated, open-label, single-arm, multicenter, phase II clinical trial.
未提供0 个研究点目标入组 29 人开始时间: 2019年9月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 主要终点
- -
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-randomized Controlled Trial
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 79age old under（—）
- 性别
- All
入选标准
- •Older than or equal to 20 years old, younger than 80 years old
- •Diagnosis of meningioma (WHO Grade I - III)
- •History of tumor resection and radiation therapy for meningioma
- •Evidence of recurrence or progression of meningioma after the last treatment for meningioma, and patients who meet either of the following conditions
- •(1) Neither tumor resection nor radiation therapy is deemed effective for the recurrent/progressive meningioma
- •(2) Patient who does not wish to have further treatment by tumor resection or radiation therapy
- •Patient who have passed a certain period of time since the last treatment.: 4 weeks after tumor resection. 1 week after biopsy. 12 weeks after radiation therapy/chemotherapy/medication therapy/immunotherapy. It is not necessary to pass 12 weeks, in the case of recurrence or progression out of the radiation field.
- •Patient with a lesion difined as measurable lesion in RANO(meningioma) with diagnostic imaging taken within 14 days before registration.
- •Patient who is possible to submit tumor tissue sample which was daignosed with menigioma.
- •Karnofsky Performance Status more than or equal to 70%.
- •Patients expected to survive 12 weeks or more at the time when the consent is obtained.
- •Patient with adequate laboratory data.
排除标准
- •Cooccurence of cancer other than meningioma. However, completely resected basal cell carcinoma, Stage I squamous cell carcinoma, carcinoma in situ, superficial bladder carcinoma, or any other cancer without recurrence for more than 3 years are allowed.
- •Comorbid autoimmune diseases or history of chronic or recurrent autoimmune diseases.
- •Patient with intracranial hemorrhage with diagnositc imaging taken within 14 days before registration.
- •Patient with uncontrollable hypertension despite appropriate treatment.
- •Central nervous system diseases other than meningioma (eg, epilepsy, etc.) that are not well controlled or may lead to discontinuation of the investigational drug.
- •Patient has or previously had a history of pulmonary hemorrhage/hypoemia.
- •Patient has or previously had a history of hereditary hemorrhagic predisposition or serious coagulation disorders at risk of hemorrhage.
- •Patient undergoing anticoagulation therapy excluding for preventive medication.
- •Patient with active gastrointestinal ulcer or gastrointestinal bleeding.
- •Patient with a history of cerebral infarction or arteriovenous thromboembolism within 180 days before registration.
- •Patient with uncontrollable or serious cardiovascular disease.
- •Patient with uncontrollable diabetes mellitus.
- •Patient with infections requiring systemic treatment.
- •Patient with pulmonary fibrosis or interstitial pneumonia.
- •Patient being treated with immunosuppressants.
- •Patient being treated with corticosteroids. Use of 2.0 mg / day or less of dexamethasone or 10 mg / day or less of prednisolone is acceptable. Short-term use of corticosteroids for the prevention of anaphylaxis, topical (skin, airway etc) corticosteroids use is acceptable.
- •Patient who can not or do not wish to have MRI imaging or contrast-enhanced MRI imaging due to pacemaker, implantable defibrillator use or contrast agent allergy.
- •Patient with a history of anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, anti-CTLA-4 antibody or other antibody or drug therapy aimed at T cell control.
- •Patient judged to lack consent ability. (e.g. dementia)
结局指标
主要结局
-
Response rate according to iRANO (meningioma) (independent review facility)
次要结局
- Response rate according to RANO (meningioma)
- Response rate according to iRANO (meningioma)
- Progression-free survival
- Best overall response according to iRANO (meningioma)
- Best overall response according to RANO (meningioma)
- Response rate according to Macdonald criteria
- Tumor volume reduction rate (by SPD, iRANO (meningioma))
- Progression-free survival rate for 6 months(6 months)
- Best overall response according to Macdonald criteria
- Overall survival
- Type, frequency and severity of adverse events (CTCAE ver. 4.0)