A Phase II Trial Using a Universal GM-CSF-Producing and CD40L-Expressing Bystander Cell Line (GM.CD40L) in the Formulation of Autologous Tumor Cell-Based Vaccines for Patients With Malignant Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Number of Participants With Partial Response
研究概览
简要总结
The purpose of this study is to find out what effects (good and/or bad) this new cancer vaccine has on the patient and their cancer, whether it is safe and whether it can help get rid of their cancer (malignant melanoma). We want to check how the patient's immune system reacts, both before and after the vaccine treatment.
详细描述
The vaccine will be made by mixing two kinds of cells: 1) some of the patient's own malignant melanoma cells which were removed by surgery and then processed in the Cell Therapy Laboratory, and 2) experimental "bystander" cells. All the cells in the vaccine will be treated with high-dose X-rays to make sure that none of them grow and cause more cancer. The bystander cells, called "GM.CD40L", are human cells that have been genetically changed. The original cells, called K562, had the genes for human GM-CSF and CD40L inserted into them. These changes are designed to help boost the patient's immune system to better fight the cancer in their body.
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
- •Histologically confirmed stage IIIC or stage IV melanoma
- •Measurable disease
- •Age 18 or older
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •No radiation therapy within 2 weeks prior to first vaccine administration
- •No chemotherapy within 4 weeks prior to first vaccine administration
- •No steroid therapy within 4 weeks prior to first vaccine administration
- •No surgery within 10 days prior to first vaccine administration
- •Patient's written informed consent
- •Patient's ability to comply with the visit schedule and assessments required by the protocol
- •Adequate organ function (measured within a week of beginning treatment):
- •White blood count (WBC) > 3,000/mm^3 and absolute neutrophil count (ANC) >1500/mm^3
- •Platelets > 100,000/mm^3
- •Hematocrit > 25% and Hgb > 8 g/dL
- •Bilirubin < 2.0 mg/dL
- •Creatinine < 2.0 mg/dL, or creatinine clearance > 60 mL/min
排除标准
- •Symptomatic or untreated brain metastasis
- •Any serious ongoing infection
- •Current corticosteroid or other immunosuppressive therapy
- •Any other pre-existing immunodeficiency condition (including known HIV infection)
- •Pregnant or lactating women -- Patients in reproductive age must agree to use contraceptive methods for the duration of the study (*A pregnancy test will be obtained before treatment)
- •ECOG performance status of 2, 3, or 4
- •Any second active primary cancer
研究组 & 干预措施
Vaccine Therapy
Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.
干预措施: Bystander-Based Autologous Tumor Cell Vaccine (Biological)
结局指标
主要结局
Number of Participants With Partial Response
时间窗: Average of 14 months
Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
次要结局
- Overall Survival (OS) in Months(Average of 14 months)
- Number of Participants With Serious Adverse Events (SAEs) Related to Study Treatment(Average of 14 months)
- Number of Participants With Stable Disease(Average of 14 months)
- Time to Progression (TTP) in Months(Average of 14 months)