Allogeneic Vaccine Modified to Express HLA A2/4-1BB Ligand for High Risk or Low Residual Disease Melanoma Patients
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 50
- 主要终点
- Number of adverse effects
研究概览
简要总结
This study is based on the hypothesis that stimulation of the immune response against the tumor can help destroy residual tumor in melanoma patients with very high risk for disease recurrence and in patients with relatively low tumor burden who already got first line treatment for their disease.
Ongoing clinical trials in the Hadassah Hospital have shown that vaccination of patients with a cell line of tumor cells from the patient himself, or with a combination of three cell lines that partially match the patient's cell characteristics, could improve the immune response against the tumor, was associated with improved disease-free and overall survival.
In this study, the investigators will evaluate the efficacy of a modified tumor cell vaccine, in terms of immune response,improved disease-free and overall survival. The vaccine consists of a cell line that has a high expression level of melanoma molecules, and has been genetically modified to induce a strong immune response.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients included in this protocol must carry one or more of the following tissue typing alleles: HLA-A2, -A24, -A33, -B35, -B49, -CW04/12(04/08). We estimate that 50% of melanoma patients will be eligible.
- •Cutaneous malignant melanoma AJCC stage IIb (over 4 mm) or IIc (ulcerated melanoma over 4mm).
- •Metastatic melanoma AJCC stage III (nodal involvement, N1-3a,b) post surgical removal of lymph nodes.
- •Metastatic melanoma AJCC stage IV, completely resected.
- •Non cutaneous malignant melanoma of respective stages including uveal and mucosal melanoma.
- •Melanoma can be of either mutant or wild-type B-RAF.
- •Karnofsky performance status over 80 (Normal activity with effort).
- •No active cardio-respiratory disease.
- •Hematocrit over 25% and WBC over
- •Informed consent of the patient.
排除标准
- •Administration of cytotoxic drugs or extensive radiotherapy less than 28 days prior to protocol administration.
- •Active brain metastases requiring cortico-steroids.
- •Concurrent malignancy (other than skin cancer, carcinoma in situ of cervix and early stage prostate cancer).
- •Active serious infection.
- •Allergy to penicillin.
- •Patient's wish to withdraw from the study at any stage.
研究组 & 干预措施
Melanoma vaccine
干预措施: Melanoma vaccine modified to express HLA A2/4-1BB ligand (Biological)
结局指标
主要结局
Number of adverse effects
时间窗: For 20 weeks from the start of treatment
次要结局
- Overall and disease free survival(For at least five years)