NCT01258868终止1 期
Epigenetically-Modified Autologous Tumor Cell Vaccines With ISCOMATRIX(TM) Adjuvant and Oral Celecoxib in Patients Undergoing Resection of Lung and Esophageal Cancers, Thymic Neoplasms, Thoracic Sarcomas, and Malignant Pleural Mesotheliomas
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Tabulation of patient toxicities and their grades
研究概览
简要总结
Background:
- Recent research has shown that causing an immune response to tumor cells may help slow or stop the growth of tumors. One treatment that has come from this research involves collecting and modifying a cancer patient's tumor cells in the laboratory, then returning the cells to the patient as a vaccine to encourage the immune system to respond to them. Researchers are interested in testing tumor cell vaccines with an experimental drug called ISCOMATRIX , which can be added to a vaccine in order to elicit a stronger immune response in the body. ISCOMATRIX has not been approved for sale and use in any country and its use is still experimental, though it has been tested and used safely in other clinical studies. Researchers are also interested in determining whether the anti-inflammatory drug celecoxib will improve the body's immune reaction if given with the vaccine.
Objectives:
- To assess the safety and effectiveness of tumor cell vaccines given with ISCOMATRIX and celecoxib in the treatment of lung and esophagus cancers.
Eligibility:
- Individuals at least 18 years of age who have primary small cell or non-small cell lung cancer, esophageal cancer, or pleural mesothelioma that can be removed by surgery.
- Only individuals whose tumor cells are able to produce a tumor cell line for vaccine development will be eligible for treatment.
Design:
- Participants will be screened with a physical examination and medical history, and will have tumor tissue collected during their surgery to determine whether the tumor cells can be used to produce a vaccine.
- Participants will take celecoxib twice daily for 7 days before having the first tumor cell vaccination. Participants will also have leukapheresis to collect blood cells for testing before the first vaccination.
- Participants will receive one vaccine (which may be given in two shots) monthly for 6 months, and will continue to take celecoxib twice daily. One month after the 6th vaccine shot, participants will have another leukapheresis and skin test. If these tests show that a participant is responding to the vaccine, additional vaccines will be given every 3 months for up to 2 years.
- Participants will have a physical exam and lab tests before each vaccination, blood samples and imaging studies every 3 months, and a skin test every 6 months.
- Participants will have regular followup visits with imaging studies and blood samples for up to 5 years after the first vaccination, or until a new tumor develops.
详细描述
Background:
- Cancer-testis (CT) antigens have emerged as attractive targets for cancer immunotherapy. Whereas lung and esophageal cancers, thymic Neoplasms, primary thoracic sarcomas, as well as malignant pleural mesotheliomas express a variety of CT antigens, 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 with resectable primary neoplasms involving the lungs, esophagus, or pleura will be vaccinated with autologous tumor cells exposed exvivo to decitabine and radiation following completion of appropriate combined modality therapy. Vaccine will be administered in conjunction with ISCOMATRIX adjuvant and oral celecoxib.
Primary Objective:
- To assess the safety of an epigenetically modified autologous tumor cell vaccine in conjunction with celecoxib.
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
Experimental
Celebrex+ tumor cell vaccine
干预措施: Celebrex (Drug)
1
Experimental
Celebrex+ tumor cell vaccine
干预措施: Tumor cell vaccine (Biological)
结局指标
主要结局
Tabulation of patient toxicities and their grades
时间窗: 30 days after last vaccine (up to 25 months)months)
次要结局
- Number of patients of the first 10 sarcoma, mesothelioma and esophageal CA patients respectively with cell line development greater than or equal to 3(When 10 patients each of the other tumor types have been recruitedother tumor types have beenrecruited)
- Enumeration and description of immune responses(2 years after initial vaccination)
- Number of patients of first 20 lung CA patients with cell line development greater than or equal to 5.(when 20 lung cancer patients have been recruitedhave been recruited)
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
Tumor Cell Vaccines and ISCOMATRIX With Chemotherapy After Tumor RemovalEpithelial MalignanciesPleural MalignancyMelanomaSarcomaNCT01341496National Cancer Institute (NCI)41
招募中
1 期
Autologous and Allogeneic Whole Cell Cancer Vaccine for Metastatic TumorsKidney CancerBreast CancerColorectal CancerLung CancerOvarian CancerGastric CancerMelanomaNCT00722228Hadassah Medical Organization50
已完成
2 期
Tumor Cell Vaccine in Treating Patients With Advanced CancerUnspecified Adult Solid Tumor, Protocol SpecificNCT00002505Hoag Memorial Hospital Presbyterian
终止
1 期
Vaccine Therapy in Patients With Stages IIIB/IV Non-Small Cell Lung Cancer Who Have Finished First-Line ChemotherapyLung CancerNCT00534209University of Miami1
终止
1 期
Vaccine Therapy in Treating Patients With HER2/Neu Positive or Negative Stage IV Breast Cancer or Other HER2/Neu Positive CancersUnspecified Adult Solid Tumor, Protocol SpecificBreast CancerNCT00095862Wiseman Research Initiatives LLC24
