A NON-COMMERCIAL, MULTICENTER, RANDOMIZED, TWO-ARMED, OPEN-LABEL PHASE III STUDY TO EVALUATE THE ADJUVANT VACCINATION WITH TUMOR RNA-LOADED AUTOLOGOUS DENDRITIC CELLS VERSUS OBSERVATION OF PATIENTS WITH RESECTED MONOSOMY 3 UVEAL MELANOMA
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- Prolongation of Overall survival
研究概览
简要总结
Patients suffering from uveal melanoma (typed positive for monosomy 3 and without evidence for metastases) will be vaccinated over a period of 2 years with Dendritic Cell loaded with autologous Tumor RNA.
200 patients will be included. The Trial is an open multicenter Phase III Trial.
详细描述
Trial arm A (DCaT-RNA) = Experimental intervention: Patients in arm A receive 8 vaccinations over a period of 2 years consisting of autologous, mature, monocyte-derived Dendritic Cells loaded with autologous tumor RNA (20 mio DC per vaccination); cells are given via intravenous infusions; vaccinations are followed by a 1 year observation (staging every 3 months)
Trial arm B (Observation) = Control: Patients in arm B receive standard care (observation only with staging every 3 months)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must suffer from melanoma of the uvea (stage T2, T3 and T4 [AJCC TNM grading 2009]).
- •Uveal melanoma must be resected and display a monosomy for chromosome 3 (will be determined by a validated qualitative analysis of loss of heterozygosity). Tumor material has to be stored appropriately in RNAlater solution for RNA preparation.
- •The patient has to be free of detectable tumor at the time point of study enrollment (adjuvant setting), as assessed by clinical inspection, abdominal sonography, chest X-ray and evaluation of the tumor-marker S-100..
- •Patients must have a WHO performance status of 0, 1 or 2 and must be in stable medical condition.
- •Patients must be between 18 and 75 years old and must be able and willing to give informed consent.
- •Women of child-bearing age must have a negative pregnancy test, and must oblige to use effective contraception until at least 4 weeks after the last vaccination.
- •Patients must be willing to get hospitalized for at least 4 hours following vaccination(s), and to cooperate for the whole period of the trial.
- •Patients must have fully recovered from surgery.
- •Signed informed consent
排除标准
- •Any other major serious illness [e.g. active systemic infections, immunodeficiency disease, clinically significant heart disease, respiratory disease, bleeding disorders, cancer etc.] or a contraindication to leukapheresis.
- •Evidence for HIV-1, HIV -2, HTLV-1, HBV, or HCV infection.
- •Active autoimmune disease (such as but not limited to Lupus erythematosus, autoimmune thyroiditis or uveitis, multiple sclerosis, inflammatory bowel disease). Vitiligo and pathological laboratory results (autoantibodies) without clinical symptoms are, however, not an exclusion criterion.
- •Previous splenectomy or radiation therapy to the spleen.
- •Patients with organ allografts.
- •Concomitant treatment with chemotherapy, immunotherapy, any investigational drug and paramedical substances. Patients may receive concomitant medications to control symptoms such as analgetics, antihypertensive medication, etc.
- •History of other active malignant neoplasm within the preceding 5 years (excluding non-melanoma skin cancer or carcinoma in situ of the cervix).
- •Organic brain syndrome or significant psychiatric abnormality which would impede informed consent and / or AND preclude participation in the full protocol and follow up.
- •Positive pregnancy test / Pregnancy or lactation. If pregnancy occurs during the course of the trial to female patients in arm A or B, the patient has to be excluded.
- •Detection of metastases. If uveal melanoma metastases appear during the course of the trial, the patient has to be excluded.
- •Lack of compliance of the patient.
研究组 & 干预措施
A
Biological/Vaccine; Autologous Dendritic Cells loaded with autologous Tumor RNA
干预措施: Autologous Dendritic Cells loaded with autologous Tumor RNA (Biological)
B
Control, Standard of care, which is clinical control every 3 months
结局指标
主要结局
Prolongation of Overall survival
时间窗: Assessment every 3 months
Clinical staging every 3 months from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months, followed by telephone interviews.
次要结局
- Prolongation of disease free survival(Assessment every 3 months)
研究者
PD Dr. med. univ. Beatrice Schuler-Thurner
Coordinating Investigator
University Hospital Erlangen