NCT01291420已完成1 期
Therapeutic Efficacy of Wilms' Tumor Gene (WT1) MRNA-electroporated Autologous Dendritic Cell Vaccination in Patients with Solid Tumors: a Phase I/feasibility Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Immunogenicity of intradermal DC vaccination
研究概览
简要总结
The aim of this study is to evaluate the immunogenicity and clinical efficacy of intradermal vaccination with autologous RNA-modified dendritic cells (DCs) - engineered to express the WT1 protein - in patients with limited spread metastatic solid tumors, i.e. breast cancers, glioblastoma grade IV, sarcomas, malignant mesothelioma and colorectal tumors. Based on the results of our previously performed phase I study with autologous WT1 mRNA-transfected DC, the investigators hypothesize that the vaccination with DC will be well-tolerated and will result in an increase in WT1-specific CD8+ T cell responses.
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
- •Tumor type:
- •Metastatic or Locally Advanced Breast Cancer; Malignant Mesothelioma; Glioblastoma Multiforme (Grade IV); Sarcoma's; Colorectal tumors or rare tumors (less than 500 patients a year)
- •Extent of disease:
- •Metastatic Breast Cancer or High Risk Locally Advanced Breast Cancer
- •Partial or Complete response after first line chemotherapy for both metastatic or locally advanced breast cancer. Minimal metastatic disease under hormonal treatment
- •High risk Locally Advanced breast cancer defined as (and/or):
- •Age < 60 years old
- •ER, PR and Her-2 Neu negative tumors
- •> 4 lymphnodes at initial presentation
- •Mastitis Carcinomatosis
- •Pregnancy associated Breast Cancer
- •Malignant Mesothelioma:
- •Partial or Complete response after first line chemotherapy not amendable for surgery
- •Adjuvant after debulking surgery
- •Glioblastoma Multiforme
- •In Recurrent Disease after optimal treatment according to Stupp regimen
- •In primary disease after debulking surgery, Temodal/radiotherapy and Temodal chemotherapy for 6 months
- •Sarcoma's
- •After adjuvant chemotherapy for uterine sarcoma's
- •After Optimal or Debulking Surgery for liposarcoma's, synovial cell sarcoma's
- •Recurrent sarcoma's with limited disease
- •Colorectal tumors
- •K-ras wild-type tumors with inoperable lymphnode metastasis after standard chemotherapy (FOLFOX, FOLFIRI)
- •Patient Characteristics
- •Prior treatments: Patients must have received at least one prior chemotherapeutic regimen and must be more than 1 month past the last treatment.
- •Age: ≥ 18 years old
- •Performance status: WHO PS grade 0-1 (Appendix B)
- •Objectively assessable parameters of life expectancy: more than 3 months
- •Prior and concomitant associated diseases allowed with the exception of underlying autoimmune disease and positive serology for HIV/HBV/HCV
- •No concomitant use of immunosuppressive drugs, hormonal treatment for breast cancer is allowed in case of stable disease
- •Adequate renal and liver function, i.e. creatinin and bilirubin = 1.2 times the upper limit of normal
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •Women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation
排除标准
- •Subjects with concurrent additional malignancy (with exception of non-melanoma skin cancers and carcinoma in situ of the cervix)
- •Subjects who are pregnant
- •Subjects who have sensitivity to drugs that provide local anesthesia
- •Subjects needing corticosteroids 1 mg/kg during vaccination; corticosteroids are allowed as part of their treatment when taken ≥ 30 days before the start of vaccination.
结局指标
主要结局
Immunogenicity of intradermal DC vaccination
时间窗: up to 2 months
Immunogenicity of intradermal DC vaccination (cellular + humoral immunity against WT1 antigen) as measured by: 1. In vivo cytokine response (serum concentration of cytokines) 2. In vivo anti-WT1 antibody responses 3. In vitro T cell reactivity towards MHC class I and II-restricted WT1 epitopes by multiplex-cytokine assay using peripheral blood and DTH-infiltrating T cells 4. Delayed type hypersensitivity (DTH) responses 5. Quantitative and qualitative FACS analysis of WT1-specific-positive CD8+ T cells using HLA-A2 WT1 multimers
次要结局
未报告次要终点
研究者
Zwi Berneman
MD
University Hospital, Antwerp
研究点 (2)
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