NCT00389610已完成2 期
A Safety and Efficacy Trial of Vaccine Boosting With Lethally Irradiated Allogeneic Pancreatic Tumor Cells Transfected With the GM-CSF Gene for the Treatment of Pancreatic Adenocarcinoma
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2006年9月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Number of Patients Experiencing a Grade 3 or Above Treatment- Related Toxicity
研究概览
简要总结
This is an open label, phase II trial study of adjuvant GVAX pancreas vaccine in patients with pancreatic cancer.
详细描述
Eligible participants will receive by intradermal administration the GVAX pancreas vaccine consisting of two irradiated allogeneic pancreatic tumor cell lines transfected with the granulocyte macrophage-colony stimulating factor (GM-CSF) gene.
There will be two cohorts of research participants:
- Participants previously vaccinated with GVAX pancreas vaccine. These participants will receive booster vaccinations as a continuation of care. Vaccination repeats every 6 months in the absence of disease progression or unacceptable toxicity.
- Participants who were not previously vaccinated with GVAX pancreas vaccine (vaccine naive). These participants received priming vaccinations once a month for 3 months followed by booster vaccinations every 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Inclusion Criteria:
- •A. previously vaccinated subjects must receive Gvax vaccine previously
- •B. naïve and previously vaccinated subjects must meet the following criteria:
- •have a history of surgically resected pathologic stage 1,2 or 3 adenocarcinoma of the head, neck, tail, or uncinate of the pancreas
- •received the last anti-cancer therapy at least 28 days ago.
- •provide informed consent.
- •have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •have adequate hematologic function (Hemoglobin ≥ 9 gm/dl, Absolute neutrophil count (ANC) ≥ 1500 #/cu mm, platelets ≥100,000 K/cu mm)
- •have adequate renal function (Serum creatinine ≤ 2 mg/dL).
- •have adequate hepatic function (Bilirubin ≤ 2.0 mg/dL, unless known Gilbert's Syndrome; Aspartate Aminotransferase (AST), Alanine transaminase (ALT) and amylase ≤ 2x upper limit of normal: Alk Phosphatase ≤ 5x upper limit of normal.)
- •agree to use adequate birth control, if of childbearing potential.
排除标准
- •radiographical evidence of pancreatic cancer disease recurrence
- •documented history of autoimmune diseases including systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis
- •uncontrolled medical problems
- •systemic steroid therapy within 28 days before vaccine administration
- •anticipated need for systemic steroid therapy within 28 days after vaccine administration
- •evidence of active infections
研究组 & 干预措施
GVAX Pancreas Vaccine Naive
Experimental
Participants will receive GVAX pancreas priming vaccinations once every month for a total of 3 months and every 6 months after that, given intradermally.
干预措施: GVAX pancreas vaccine (Biological)
Previously Vaccinated With GVAX Pancreas Vaccine
Experimental
Participants receive booster vaccination every 6 months, given intradermally.
干预措施: GVAX pancreas vaccine (Biological)
结局指标
主要结局
Number of Patients Experiencing a Grade 3 or Above Treatment- Related Toxicity
时间窗: 14 years
When calculating the incidences of adverse events, each adverse event (as defined by NCI CTCAE v3) will be counted only once for a given subject.
次要结局
- Disease-free Survival (DFS)(16 years)
- Overall Survival (OS)(16 years)
研究者
研究点 (1)
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