NCT02261714已完成1 期
A Phase I/II Trial of TG01 and Gemcitabine as Adjuvant Therapy for Treating Patients With Resected Adenocarcinoma of the Pancreas
Targovax ASA5 个研究点 分布在 3 个国家目标入组 32 人开始时间: 2012年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 5
- 主要终点
- Patients' Immune Response
研究概览
简要总结
The purpose of this study is to investigate the effect of TG01 and Granulocyte macrophage colony stimulating factor (GM-CSF) when given in addition to gemcitabine (chemotherapy) and
- Understand any possible side effects of the additional use of TG01/GM-CSF with gemcitabine
- Investigate whether TG01/GM-CSF when given with gemcitabine can produce an immune response
- Investigate if the treatment can delay or reduce recurrence of the disease
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
- •Histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas
- •Stage I or II disease (clinical stage T1-3, N0-1, M0 by AJCC staging criteria).
- •Successful surgical resection
- •Complete resection (R0) or with microscopic residual disease (R1)
- •Expected to receive gemcitabine monotherapy as adjuvant chemotherapy
- •Laboratory Values:
- •Absolute neutrophil count ≥ 1.5 x 10^9/l
- •Platelets ≥100 x 10^9/l
- •Haemoglobin ≥ 9 g/dl
- •Total bilirubin ≤ 1.5 x UNL
- •Serum creatinine ≤ 1.5 x UNL
- •Albumin ≥ 2.5 g/dl
- •AST or ALT ≥ 5 x UNL
- •18 years of age or older.
- •ECOG performance status (PS) of 0-
- •Life expectancy of at least 6 months
- •Men and women of childbearing potential must be willing to use effective methods of contraception to prevent pregnancy
- •Provide written (signed) informed consent to participate in the trial prior to any trial specific screening procedures
排除标准
- •Has received an investigational drug within 4 weeks prior to Trial drug administration
- •Has received previous therapy for pancreatic cancer including radiation or chemotherapy (except for the primary resection or primary neoadjuvant chemotherapy).
- •Is currently receiving any agent with a known effect on the immune system, unless at dose levels that are not immunosuppressive (e.g. Prednisone at 10 mg/day or less or as inhaled steroid at doses used for the treatment of asthma).
- •Has any other serious illnesses or medical conditions such as, but not limited to:
- •Any uncontrolled infection
- •Uncontrolled cardiac failure classification III or IV (NY Heart Association)
- •Uncontrolled systemic and gastro-intestinal inflammatory conditions
- •Bone marrow dysplasia
- •History of auto-immune disease
- •History of adverse reactions to vaccines
- •Known history of positive tests for HIV/AIDS, hepatitis B or C
- •Pregnant or lactating females or have no pregnancy test at baseline (postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential).
- •Contraindication to gemcitabine treatment
- •Have had any other malignancies within last 3 years (except for adequately treated carcinoma of the cervix or basal or squamous cell skin cancer)
- •Known malignant brain lesion(s)
- •Are unlikely to start chemotherapy within 12 weeks of surgery (e.g. delayed wound healing, or infection, etc.)
- •Are not expected to complete 6 cycles of chemotherapy
- •Are planned to receive yellow fever or other live (attenuated) vaccines during the course of study
研究组 & 干预措施
TG01/GM-CSF and Gemcitabine
Experimental
干预措施: TG01 (Biological)
结局指标
主要结局
Patients' Immune Response
时间窗: During the 2 years of treatment
Assess the Immune response (DTH responses and Proliferative T-cell responses) up to 2 years of treatment
Patients' Safety During Study
时间窗: 2 years
Assess the safety (number and nature of Adverse events and laboratory data occurring during study (before, during and after chemotherapy is given) in subjects treated with the Pancreatic Cancer ASCI
次要结局
- Clinical Efficacy(DFS was followed for up to 2 years and OS until last patient included had been in the study for 3 years.)
研究者
研究点 (5)
Loading locations...
相似试验
进行中（未招募）
1 期
A Phase I/II Trial of TG01 and Gemcitabine as adjuvant therapy for treating patients with pancreatic cancerAdenocarcinoma of the PancreasMedDRA version: 19.0Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 100000004864EUCTR2012-002400-40-GBTargovax ASA32
进行中（未招募）
1 期
A Phase I/II Trial of TG01 and Gemcitabine as adjuvant therapy for treating patients with pancreatic cancerAdenocarcinoma of the PancreasMedDRA version: 18.0Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 100000004864EUCTR2012-002400-40-ESTargovax AS32
进行中（未招募）
1 期
A Phase I/II Trial of TG01 and Gemcitabine as adjuvant therapy for treating patients with pancreatic cancerAdenocarcinoma of the PancreasMedDRA version: 15.0Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-002400-40-NOTargovax AS24
终止
2 期
Phase II Study of Gemcitabine and TS-1 in Biliary Trat CancerBiliary Tract CancerNCT01171755Samsung Medical Center19
已完成
1 期
Gemcitabine With Antiangiogenic Peptide Vaccine Therapy in Patients With Pancreatic CancerPancreatic CancerNCT00622622Wakayama Medical University21