A Safety and Efficacy Trial of Lethally Irradiated Allogeneic Pancreatic Tumor Cells Transfected With the GM-CSF Gene in Combination With Adjuvant Chemoradiotherapy for the Treatment of Adenocarcinoma of the Pancreas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
RATIONALE: Vaccines made from gene-modified pancreatic cancer cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving vaccine therapy together with chemotherapy and radiation therapy after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with adjuvant chemoradiotherapy works in treating patients with resected stage I or stage II adenocarcinoma (cancer) of the pancreas.
详细描述
OBJECTIVES:
Primary
- Determine overall and disease-free survival of patients with resected stage I or II adenocarcinoma of the pancreas treated with adjuvant chemoradiotherapy in combination with GVAX pancreatic cancer vaccine.
Secondary
- Correlate specific in vivo parameters of immune response (post-vaccination delayed-type hypersensitivity reactions to autologous tumor, mesothelin-specific T-cell response, and the degree of local eosinophil, macrophage, and T-cell infiltration at the vaccine site) with clinical responses in patients treated with this regimen.
- Determine the toxic effects associated with intradermal injections of this vaccine in these patients.
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
- •DISEASE CHARACTERISTICS:
- •* Histologically confirmed invasive ductal adenocarcinoma of the head, neck, and uncinate process of the pancreas
- •* Mixed adenocarcinoma tumors allowed if the predominant invasive component of the tumor is adenocarcinoma
- •* Stage I or II (clinical stage T1-3, N0-1, M0) disease
- •* Has undergone pancreaticoduodenectomy at the Johns Hopkins Hospital within the past 8-10 weeks
- •* Completely resected (R0) or microscopic residual (R1) disease
- •* No diagnosis other than ductal adenocarcinoma, including any of the following:
- •* Adenosquamous
- •* Squamous cell
- •* Islet cell
- •* Non-invasive intraductal papillary mucinous neoplasms
- •* Serous or mucinous cystadenoma or cystadenocarcinoma
- •* Carcinoid
- •* Small or large cell carcinoma
- •* Intraductal oncocytic papillary neoplasms
- •* Osteoclast-like giant cell tumors
- •* Acinar cell carcinoma
- •* Pancreatoblastoma
- •* Solid pseudopapillary tumors
- •* Undifferentiated small cell carcinoma
- •* Non-epithelial tumors (sarcoma, gastrointestinal stromal tumor, or lymphoma)
- •* Adenocarcinoma of the ampulla
- •* Adenocarcinoma of the distal bile duct
- •* Adenocarcinoma of the duodenum
- •* No recurrent disease
- •* No metastatic disease, including peritoneal implants or liver and/or lung involvement
- •PATIENT CHARACTERISTICS:
- •* 18 and over
- •Performance status
- •* ECOG 0-1
- •Life expectancy
- •* Not specified
- •Hematopoietic
- •* Absolute neutrophil count \>/= 1,500/mm\^3
- •* Platelet count \>/= 100,000/mm\^3
- •* Hemoglobin \>/= 10 g/dL
- •* Bilirubin \/= 1,500 calories/day, ongoing requirement for long-term biliary stenting, or persistence of wound infection)
- •* No other malignancy within the past 5 years except nonmelanoma skin cancer
- •* No uncontrolled medical conditions that would preclude study participation
- •* No other major active medical or psychosocial problem that could be exacerbated by study treatment
- •* Not pregnant or nursing
- •* Negative pregnancy test
- •* Fertile patients must use effective contraception during and for at least 4 weeks after study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •* More than 1 month since prior biologic therapy
- •* No other concurrent biologic therapy, immunotherapy, or gene therapy for pancreatic cancer
- •Chemotherapy
- •* More than 1 month since prior chemotherapy
- •* No other concurrent chemotherapy for pancreatic cancer
- 另有 10 项未显示
排除标准
- 未提供
研究组 & 干预措施
GVAX pancreatic cancer vaccine
5E8 vaccine cells. The first vaccination is administered 6-8 weeks after surgery. Four to eight weeks following the completion of the last cycle of adjuvant radiation and chemotherapy (chemo-radiation therapy is standard of care and not part of the protocol) eligible patients will receive three additional vaccinations at one month intervals. Patients who continue to remain disease-free will receive a fifth "booster" vaccination, six months following the fourth vaccination
干预措施: GVAX pancreatic cancer vaccine (Biological)
结局指标
主要结局
Overall Survival
时间窗: Participants were followed for the duration of the study, an average of 2 years
Overall survival in patients treated with adjuvant chemoradiotherapy in sequence with the irradiated allogeneic GM-CSF transfected pancreatic tumor cell lines. Overall survival is defined as time from surgery until death, regardless of cause.
Disease-free Survival
时间窗: Participants were followed for the duration of the study, an average of 2 years
Disease-free Survival in Patients Treated With Adjuvant Chemoradiotherapy in Sequence With the Irradiated Allogeneic GM-CSF Transfected Pancreatic Tumor Cell Lines. DFS is defined as time from surgery until clinical evidence of disease (eg, CT scan) or death due to any cause.
次要结局
- To Further Identify and Characterize Toxicities Associated With Intradermal Injections of the Vaccine That Were Initially Reported in the Phase 1 Trial.(4 years)
- Estimate the Association of Specific in Vivo Parameters of Immune Response With Clinical Responses in Patients Treated With Combination Chemoradiotherapy Together With the Irradiated Allogeneic GM-CSF Transfected Pancreatic Tumor Cell Lines.(Continuous)