Pilot Clinical Trial of Allogeneic Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccination in Newly Diagnosed Glioblastoma
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Incidence of significant toxicity, defined as grade 3 or higher adverse event that is possibly, probably, or definitely related to treatment measured using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
研究概览
简要总结
This pilot clinical trial studies vaccine therapy and temozolomide in treating patients with newly diagnosed glioblastoma. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vaccine therapy and temozolomide may be an effective treatment for glioblastoma.
详细描述
PRIMARY OBJECTIVES:
I. To determine the safety and feasibility of adjuvant temozolomide plus combined allogeneic tumor primary tumor culture lysate / autologous dendritic cell (DC) vaccination (malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine) in newly diagnosed glioblastoma patients following surgical debulking and external beam radiation therapy with concurrent temozolomide.
SECONDARY OBJECTIVES:
I. To document survival and progression-free survival in newly diagnosed glioblastoma patients receiving adjuvant temozolomide plus allogeneic tumor primary tumor culture lysate / autologous DC vaccination 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
- •Willing and capable of undergoing apheresis for collection of mononuclear cells
- •Histologically confirmed GBM (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
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
- •Absolute neutrophil count (ANC) >= 1500 / uL
- •Platelets (PLT) >= 100,000 / uL
- •Hemoglobin (HgB) >= 9.0 g/dL
- •Total bilirubin =< 1.5 x upper normal limit (UNL)
- •Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3 x UNL
- •Creatinine =< 1 x UNL
- •Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
- •Ability to understand and willingness to sign a written informed consent
- •Willing to return to Mayo Clinic Rochester 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
- •Completed standard external beam radiation with temozolomide
- •Achieved a gross total or sub-total resection at time of surgery
排除标准
- •Current or prior treatment for this cancer with immunotherapy and/or any other investigational agents
- •Any of the following
- •Pregnant women
- •Nursing women
- •Men or women 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 including treated lower grade gliomas; EXCEPTIONS: non-melanotic skin cancer, carcinoma-in-situ of the cervix, or lower grade glioma that has never been treated previously; 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) on day of 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)
研究组 & 干预措施
Treatment (vaccine therapy and temozolomide)
COURSE 1: Patients receive temozolomide PO daily on days 1-5.
COURSES 2-3: Patients receive temozolomide PO daily on days 1-5 and malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on days 1, 3, and 5.
COURSES 4-6: Patients receive temozolomide PO daily on days 1-5 and malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on day 1.
COURSES 7-12: Patients receive malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on day 1.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (vaccine therapy and temozolomide)
COURSE 1: Patients receive temozolomide PO daily on days 1-5.
COURSES 2-3: Patients receive temozolomide PO daily on days 1-5 and malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on days 1, 3, and 5.
COURSES 4-6: Patients receive temozolomide PO daily on days 1-5 and malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on day 1.
COURSES 7-12: Patients receive malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on day 1.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Malignant Glioma Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccine (Biological)
Treatment (vaccine therapy and temozolomide)
COURSE 1: Patients receive temozolomide PO daily on days 1-5.
COURSES 2-3: Patients receive temozolomide PO daily on days 1-5 and malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on days 1, 3, and 5.
COURSES 4-6: Patients receive temozolomide PO daily on days 1-5 and malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on day 1.
COURSES 7-12: Patients receive malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on day 1.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Temozolomide (Drug)
结局指标
主要结局
Incidence of significant toxicity, defined as grade 3 or higher adverse event that is possibly, probably, or definitely related to treatment measured using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
时间窗: Up to 84 days
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
- Duration of response(Up to 5 years)
- Overall response rate(Up to 5 years)
- Time to response(Up to 5 years)
- Change in immunologic correlates(Baseline to up to 5 years)
- Clinical benefit rate(Up to 5 years)