JPRN-jRCT2031200153招募中3 期
Randomized phase III clinical trial on the therapeutic effect of Cellm-001 for newly diagnosed glioblastoma.
Muragaki Yoshihiro0 个研究点目标入组 112 人开始时间: 2020年10月14日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 112
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •(1) 18 years old or older and 75 years old or younger.
- •(2) Newly diagnosed and histologically confirmed supratentorial glioblastoma (WHO grade IV) without dissemination on the image.
- •(3) Maximum surgical resection was performed at the initial onset and the tumor contrast area on the image was completely removed.
- •(4) About 5 g of excised tumor tissue by wet weight at the time of excision.
- •(5) Karnofsky Performance Status (KPS) is 60 or higher and a prognosis of 3 months or longer is expected.
- •(6) In the planned radiotherapy, it has been confirmed that the planned target volume to be irradiated up to 60 Gy is less than 1/3 of that of the cerebrum and diencephalon.
- •(7) All of the following conditions are met. For all inspection items, use the latest inspection values within 14 days from the date of registration.
- •Neutrophil count >= 500/mm^3, hemoglobin >= 6.0 g/dL, Platelet count >= 5 x 10^4 / mm^3, AST (GOT) =< 5 x the upper limit of normal (ULN) for the reference lab, ALT (GPT) =< 5 x the upper limit of normal (ULN) for the reference lab, serum creatinine =< 1.5 mg/dL.
- •(8) Patient informed his/her diagnosis and the patient or a legitimate substitute if the patient is a minor has enough ability to comprehend and consent to the study.
- •(9) Study drug administration and follow-up will be performed under the study participating institutions.
排除标准
- •(1) Systemic administration of corticosteroids (prednisolone greater than 10 mg / day, or equivalent amounts) within 14 days prior to enrollment or other immunosuppressive agents or complications of active and serious autoimmune disease.
- •(2) A patient who was implanted of carmustine intracerebral wafers in the surgical cavity.
- •(3) Bevacizumab (an antineoplastic agent) was used or will be used.
- •(4) Tumor Treating Fields ( Novo TTF-100A ) system will be used.
- •(5) Significant increased intracranial hypertension that a patient is not expected to be completely treated with radiation therapy.
- •(6) Active complications that may be difficult to carry out with this treatment.
- •(7) A patient having an infectious disease requiring systemic treatment within 7 days prior to registration.
- •(8) A patient with an active malignant tumor (simultaneous double cancer and metachronous double cancer with a disease-free period of 5 years or less ) except malignant glioma. However, carcinoma in situ or intramucosal cancer (curable cancer by local treatment) is not included in active double cancers.
- •(9) A pregnant woman, a nursing woman who does not wish to stop breastfeeding and a woman who may or will be pregnant.
- •(10) A patient who is difficult to participate in the study because of a mental illness or psychiatric symptom that interferes with daily life.
- •(11) Participated in a clinical trial for other therapeutic purpose within 6 months prior to enrollment or is currently participating in a clinical trial for other therapeutic purpose.
- •(12) With regard to hepatitis B or C, acute or persistent infection or virus is detectable.
- •(13) Known HIV-positivity.
- •(14) Due to a drug allergy, any MRI contrast agent (gadolinium contrast agents, etc.) can not be used.
- •(15) A patient with hypersensitivity reaction to the ingredients of this drug. Hypersensitivity reaction due to the components of this drug refers to pathological allergic reaction caused by autologous tumor tissue fragment, dried BCG vaccine extract, purified tuberculin or heparin sodium, except a case of delayed skin hypersensitivity that is also observed in a healthy subject with BCG vaccine and purified tuberculin and fever of CTCAE grade 3 or lower.
- •(16) A patient with a history or complication of interstitial lung disease.
- •(17) A patient judged by principal investigator to be ineligible.
研究者
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