Epigenetically-Modified Autologous Tumor Cell Vaccs and ISCOMATRIX(TM) Adjuvant With Metronomic Oral Cyclophosphamide and Celecoxib in Pts Undergoing Resection of Sarcomas, Melanomas, Germ Cell Tumors, or Epithelial Malignancies Metastatic to Lungs, Pleura or Mediastinum
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- tabulation and grade of observed patient toxicities attributed to the vaccine, and report of the fractions of patients who encounter these toxicities at the various grades
研究概览
简要总结
Background:
- A tumor cell vaccine is an experimental cancer treatment. Cancer cells are collected from a patient and then used to develop a vaccine. The vaccine will produce an immune system response to help destroy other cancer cells in the body. Researchers are studying ways to improve these tumor cell vaccines. One way is to add an adjuvant. An adjuvant is a substance that brings about a stronger immune system response. ISCOMATRIX is an adjuvant that has been used safely in other clinical studies. But it has not been studied with certain tumor cell vaccines. Researchers want to find out whether a tumor cell vaccine with ISCOMATRIX, given along with cancer drug treatment, is a safe and effective way to slow or prevent tumor growth after tumor removal surgery.
Objectives:
- To assess the safety and effectiveness of tumor cell vaccines given with ISCOMATRIX and drug therapy after tumor removal surgery.
Eligibility:
- People at least 18 years of age who have had tumor cell vaccines developed from cells taken from surgically removed tumors.
Design:
- Patients will be screened with a physical examination, medical history, blood and urine tests, and imaging studies.
- Patients will be treated with cyclophosphamide (once daily) and celecoxib (twice daily) for 7 days before the first vaccine dose.
- Patients will receive the tumor cell vaccine once a month for 6 months. They will continue to receive drug therapy throughout the vaccine treatment. Patients will be monitored with regular blood tests and imaging studies.
- After the first 6 months, patients who have an immune response to the vaccine will continue treatment with the vaccine and chemotherapy. They will also have regular blood tests and imaging studies. They will have this treatment for up to 24 months from the first vaccination or until they no longer have an immune response.
- Participants will have followup visits for up to 5 years after the first vaccination, or until the tumor returns.
详细描述
Background:
Cancer-testis (CT) antigens (CTAs) have emerged as attractive targets for cancer immunotherapy. Whereas cancers of various histologies exhibit CTA expression, primary or vaccine-induced immune responses to these antigens appear uncommon in patients with these malignancies, possibly due to low-level, heterogeneous antigen expression, and inadequate vaccination strategies. Because numerous CT antigens can be induced in tumor cells by DNA demethylating agents and HDAC inhibitors, it is conceivable that vaccination of cancer patients with autologous tumor cells exposed to chromatin remodeling agents will enhance anti-tumor immunity in these individuals. In order to examine this issue, patients undergoing complete resection of sarcomas, melanomas, germ cell tumors and epithelial malignancies metastatic to the lungs, pleura or mediastinum will be vaccinated with autologous tumor cells exposed ex-vivo to decitabine and radiation following completion of appropriate combined modality therapy. Vaccines will be administered in conjunction with ISCOMATRIX adjuvant as well as metronomic oral cyclophosphamide (50 mg PO BID x 7d q 14d), and celecoxib (400 mg PO BID). Serologic responses to a variety of recombinant CTAs as well as delayed type hypersensitivity to autologous epigenetically modified tumor cells will be assessed before and after vaccination.
Primary Objective:
-To assess the safety of an epigenetically modified autologous tumor cell vaccine administered with ISCOMATRIX adjuvant in combination with metronomic oral cyclophosphamide and celecoxib in patients undergoing thoracic metastasectomy.
Eligibility:
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
autologous tumor vaccine plus chemotherapy
干预措施: Epigenetically Modified Autologous Tumor (Biological)
1
autologous tumor vaccine plus chemotherapy
干预措施: Cyclophosphamide (Drug)
1
autologous tumor vaccine plus chemotherapy
干预措施: Celecoxib (Drug)
结局指标
主要结局
tabulation and grade of observed patient toxicities attributed to the vaccine, and report of the fractions of patients who encounter these toxicities at the various grades
时间窗: 5 years
次要结局
- Number and characteristics of immunologic responses to a panel of CT antigens in vaccinated patients(7 years)
- Determine if 5 or greater of the first 20 vaccinated patients undergoing thoracic metastasectomy have successful tumor cell line development(2-3 years)