NCT00107185已完成1 期
Phase I Dose Escalation Study of Autologous Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Malignant Gliomas in Pediatric Patients
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Dose-limiting toxicity of adjuvant vaccination with autologous tumor lysate-pulsed dendritic cells after surgical resection in pediatric patients with malignant glioma.
研究概览
简要总结
RATIONALE: Vaccines made from a person's white blood cells and tumor cells may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy after surgery may be a more effective treatment for malignant glioma.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating young patients who are undergoing surgery for malignant glioma.
详细描述
OBJECTIVES:
Primary
- Determine the dose-limiting toxicity of adjuvant vaccination with autologous tumor lysate-pulsed dendritic cells after surgical resection in pediatric patients with malignant glioma.
- Determine the maximum tolerated dose of this vaccine in these patients.
Secondary
- Determine, preliminarily, the survival of patients treated with this vaccine.
- Determine, preliminarily, the time to tumor progression in patients treated with this vaccine.
- Determine cellular immune response in patients treated with this vaccine.
- Determine age-dependent differences in response to this vaccine, in terms of immunocompetence, in these patients.
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
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed* WHO grade III or IV malignant glioma of 1 of the following subtypes:
- •Anaplastic astrocytoma
- •Anaplastic oligodendroglioma
- •Glioblastoma multiforme NOTE: *Must be confirmed after surgery
- •Newly diagnosed OR recurrent disease
- •Bidimensionally measurable disease by contrast-enhancing pre-operative MRI
- •Surgically accessible tumor for which surgical resection is indicated at the time of initial pre-operative evaluation
- •Must have undergone standard surgery* AND either radiotherapy* or chemoradiotherapy*
- •Objective evidence of disease by contrast-enhanced brain MRI after completion of standard therapy NOTE: *Completed after study entry but before assignment to study treatment cohorts
- •Age 1 to 18
- •Performance status Karnofsky 60-100%
- •Hematopoietic
- •Hemoglobin ≥ 10 g/dL
- •Absolute granulocyte count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •SGPT and SGOT ≤ 2 times normal
- •Alkaline phosphatase ≤ 2 times normal
- •Bilirubin ≤ 1.5 mg/dL
- •Hepatitis B and C negative
- •BUN ≤ 1.5 times normal OR
- •Creatinine ≤ 1.5 times normal
- •Immunologic
- •HIV negative
- •Syphilis negative
- •At least 2 weeks since prior radiotherapy and recovered
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- •No chemotherapy during and for 4 weeks* after the final dose of study vaccine
- •No corticosteroids for at least 10 days before leukapheresis
- •No concurrent corticosteroids
- •More than 72 hours since prior systemic antibiotics
- •No antihistamines for 5 days before and for 5 days after administration of study vaccine
排除标准
- •history of immunodeficiency or autoimmune disease that may be exacerbated by immunotherapy, including any of the following:
- •Rheumatoid arthritis
- •Systemic lupus erythematosus
- •Vasculitis
- •Polymyositis
- •Dermatomyositis
- •Scleroderma
- •Multiple sclerosis
- •Juvenile-onset insulin-dependent diabetes
- •active infection
- •allergy to study reagents
- •pregnant or nursing
- •other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, localized prostate cancer, or carcinoma in situ of the cervix
- •unstable or severe medical or psychiatric condition, as determined by the investigator
- •underlying condition that would preclude study participation
- •concurrent radiotherapy
- •prior organ allograft
- •concurrent strong painkillers
- •other concurrent immune-suppressing medications
- •other concurrent investigational agents
- •other adjuvant treatment for 4 weeks* after the final dose of study vaccine NOTE: *Unless there is evidence of tumor progression necessitating additional clinically-indicated treatment; patients requiring treatment due to tumor progression are removed from the study
结局指标
主要结局
Dose-limiting toxicity of adjuvant vaccination with autologous tumor lysate-pulsed dendritic cells after surgical resection in pediatric patients with malignant glioma.
时间窗: 1 year
次要结局
- survival(1 year)
研究者
研究点 (2)
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