NCT03360708已完成早期 1 期
Pilot Clinical Trial of Allogeneic Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccination in Recurrent Glioblastoma
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Incidence of significant toxicity, defined as a dose limiting toxicity (DLT) that is possibly, probably, or definitely related to treatment as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
研究概览
简要总结
This pilot early phase I trial studies the side effects of vaccine therapy in treating patients with glioblastoma that has come back. Vaccines made from a person's white blood cells mixed with tumor proteins from another person's glioblastoma tumors may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy may work better in treating patients with glioblastoma.
详细描述
PRIMARY OBJECTIVES:
I. To determine the safety and feasibility of malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine (autologous dendritic cell [DC] / allogeneic glioblastoma multiforme [GBM] culture lysate vaccination) in glioblastoma patients at first or second recurrence.
SECONDARY OBJECTIVES:
I. To document survival and progression-free survival in glioblastoma patients at first or second recurrence receiving autologous DC / allogeneic GBM culture lysate vaccination and compared to historical data.
TERTIARY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •First or second recurrence of previously histologically confirmed glioblastoma (grade 4 astrocytoma)
- •NOTE: gliosarcomas and other grade 4 astrocytoma variants (e.g., giant cell) may be included, primitive neuroectodermal tumor (PNET) variants are excluded; grade 4 oligodendrogliomas or oligoastrocytomas are specifically excluded
- •Prior craniotomy and gross total or sub-total resection of tumor at this recurrence NOTE: biopsy of this recurrence alone without attempt at resection does not meet this inclusion criteria (i.e. craniotomy and resection is still required).
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
- •Absolute neutrophil count (ANC) >= 1500/uL
- •Monocytes >= 300/uL
- •Platelets (PLT) >= 100,000/uL
- •Hemoglobin (HgB) >= 9.0 g/dL
- •Total bilirubin =< 1.5 x upper limit of normal (ULN)
- •Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3 x ULN
- •Creatinine =< 1.5 x ULN
- •Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only
- •Ability to understand and willingness to sign written informed consent
- •Willing to return to Mayo Clinic in Rochester, Minnesota for follow-up
- •Willing to provide tissue and blood samples for mandatory correlative research purposes
- •Fixed or decreasing dose of corticosteroids (or no corticosteroids) >= 7 days prior to registration
排除标准
- •Prior treatment
- •Current or prior treatment for this cancer with immunotherapy and/or any other investigational agents
- •Surgery =< 2 weeks prior to registration
- •Radiotherapy =< 12 weeks prior to registration
- •Treatment with bevacizumab or any cytotoxic chemotherapy =< 8 weeks prior to registration
- •Any of the following
- •Pregnant persons
- •Nursing persons
- •Persons of childbearing potential who are unwilling to employ adequate contraception
- •Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- •Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV), human T-cell lymphotropic virus (HTLV), hepatitis B (HepB), or hepatitis C (HepC) positive
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •History of other malignancy other than glioma
- •EXCEPTIONS: non-melanotic skin cancer, carcinoma-in-situ of the cervix, or systemic cancer that has been in documented remission for > 10 years
- •NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer
- •History of myocardial infarction =< 180 days (6 months), or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- •Active infection =< 5 days prior to registration or fever >/= 38 degrees Celsius (C) within 5 days prior to registration
- •History of tuberculosis or positive purified protein derivative (PPD) test
- •Inability or unwillingness to have magnetic resonance imaging (MRI) scans performed (e.g. cardiac pacemaker-dependent)
结局指标
主要结局
Incidence of significant toxicity, defined as a dose limiting toxicity (DLT) that is possibly, probably, or definitely related to treatment as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
时间窗: Up to 5 years
Incidence of significant toxicity will be estimated by the number of patients with significant toxicity divided by the total number of evaluable patients.
次要结局
- Clinical benefit rate(Up to 5 years)
- Progression-free survival(Time from study registration to progression and death due to any cause, assessed up to 5 years)
- Feasibility(Up to 5 years)
- Overall survival(Time from study registration to progression and death due to any cause, assessed up to 5 years)
- Overall response rate(Up to 5 years)
- Time to response(Date of initiation of vaccination treatment to the date at which the patient?s objective status is first noted to be either a CR or PR, assessed up to 5 years)
- Duration of response(Date at which the patient?s objective status is first noted to be either a CR or PR to the earliest date progression is documented, assessed up to 5 years)
研究者
研究点 (2)
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