A Phase I Trial of a Dendritic Cell Activating Scaffold Incorporating Autologous Melanoma Cell Lysate (WDVAX) in Metastatic Melanoma Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Safety and Biologic Activity of WDVAX
研究概览
简要总结
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of investigational melanoma vaccines. Phase I studies also try to define the appropriate dose of the investigational vaccine, in this case WDVAX, to use for further studies. "Investigational" means that the vaccine is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not yet approved WDVAX for any use in patients, including people with Melanoma.
The purpose of this study is to determine if it is possible to make a vaccine against melanoma by using your own melanoma tumor cells and combining them with other proteins which activate the immune system. We hope that by combining the cells and the proteins in this way that the vaccine will cause your own immune system to react against your melanoma tumor cells. The purpose of this study is also to determine the safest way to give this vaccine with the least amount of side effects.
Each vaccine will contain your own tumor cells which have been killed by a freezing and thawing process which destroys the cells but keeps the proteins from the melanoma cells. This is called a "tumor lysate" Your tumor lysate is combined with other proteins which activate the immune system. The other proteins are called GM-CSF and CpG. All of this is held together to form a "tablet" or "scaffold" which is about the size of a regular aspirin tablet. The material that holds the protein together is called PLGA. PLGA is the same material that doctors use for "dissolvable stitches" If you have ever had a problem with these types of stitches in the past, be sure to let your study doctor know about this.
详细描述
After agreeing to participate you will be asked to undergo some screening tests or procedures to confirm that you are eligible for the study. Many of these test and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. These procedures include: a medical history, physical examination, performance status, assessment of your tumor and blood tests.
If these tests show that you are eligible to participate in the research study, you will be referred to a study surgeon to prepare for the surgical removal of tumor tissue from which your vaccine will be made. If, at the time of your surgery, the surgeons are not able to obtain enough tumor cells for us to make your vaccine, then you will not be eligible to participate in this research study. The surgery will be performed at Brigham and Women's Hospital.
The total number of vaccines to be administered to each participant is four. Since we are looking for the shortest amount of time between doses that can be administered safely without severe or unmanageable side effects in participants that have melanoma, not everyone who participates in this research study will be on the same dose schedule to receive the vaccine. For example, some participants will receive the vaccine once a month for 4 doses, the next group will receive the vaccine every three weeks for 4 doses and the final group will receive the vaccine every two weeks for four doses. The schedule for your vaccination will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses.
Before each vaccination and then 24 hours after each vaccination you will have a physical exam and you will be asked questions about your general health and specific questions about any problems that you might be having and any medications you may be taking.
We will assess your tumor by CT scan and/or MRI before you start the vaccine, approximately half-way through the vaccine schedule and then one month after completion of all four vaccines. After that we will assess your tumor every three months.
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 or cytologically confirmed Stage IV melanoma
- •Life expectancy of 6 months or greater
- •At least four weeks since treatment
- •Recovered from any acute toxicity associated with prior therapy
- •At least 8 weeks since treatment with any check point blockade agent
排除标准
- •Known allergy or adverse reaction to PLG
- •Pregnant or breastfeeding
- •Receiving other investigational study agents
- •Active autoimmune disease requiring treatment for suppression of inflammation
- •Uncontrolled intercurrent illness
- •History of a different malignancy unless disease-free for at least 5 years or diagnosed and treated cervical cancer in situ, basal or squamous cell carcinoma of the skin
- •HIV positive
研究组 & 干预措施
WDVAX
Treatment
干预措施: WDVAX (Biological)
结局指标
主要结局
Safety and Biologic Activity of WDVAX
时间窗: 2 years
To determine the safety and biologic activity of vaccination with dendritic cell activation scaffolds (WDVAX) incorporating autologous melanoma cell lysates in patients with metastatic melanoma
Feasibility of WDVAX for Metastatic Melanoma
时间窗: 2 years
To determine the feasibility of preparing dendritic cells activating scaffolds (WDVAX) incorporating autologous melanoma cell lysates in patients with metastatic melanoma
次要结局
- Immune Response(2 years)
- Tumor Response(2 years)
- Response to subsequent immunotherapy (E.G., anit-CTLA-4 or anti_PD-1mAbs(2 years)
- Survival(2 years)
研究者
F. Stephen Hodi, MD
Principal Investigator
Dana-Farber Cancer Institute