A Prospective, Open Phase I Study to Investigate the Tolerability and Efficacy of ALECSAT to Pancreas Cancer Patients
A Prospective, Open Phase I Study to Investigate the Tolerability and Efficacy of Administering ALECSAT to Pancreas Cancer Patients
This study is a prospective open phase-I study to investigate the safety and tolerability for administration of repeated doses of ALECSAT.
Each patient will be followed up to 24 weeks from the initial blood donation to the last visit. However, the actual treatment starts on day 26, when the first single dose of ALECSAT is administered. The following administrations are given with 3 weeks intervals, i.e. at week 7 and 10. The patients are attending Kirurgisk afdeling K, Bispebjerg Hospital, and are followed by close examinations during the study period and at regular visits after completing the study as advised by the patient's responsible physician.
研究概览
详细说明
This study is a prospective open phase-I study to investigate the safety and tolerability for administration of repeated doses of ALECSAT.
Each patient will be followed up to 24 weeks from the initial blood donation to the last visit. However, the actual treatment starts on day 26, when the first single dose of ALECSAT is administered. The following administrations are given with 3 weeks intervals, i.e. at week 7 and 10. The patients are attending Kirurgisk afdeling K, Bispebjerg Hospital, and are followed by close examinations during the study period and at regular visits after completing the study as advised by the patient's responsible physician.
The selected group of patients suffers from locally advanced pancreatic cancer and have been treated with first line treatment regimens (e.g. surgery, radiotherapy, and/or Folfirinox) and are followed at Kirurgisk afdeling K, Bispebjerg Hospital. The subjects will be recruited consecutively and included to the study if they fulfil the inclusion criteria and do not meet any of the exclusion criteria. Potential candidates will receive oral information by the Investigator subsequent to the written patient information. The potential candidate must have the opportunity to consider the given information and to further ask the Investigator questions before finally deciding to participate. When the patient decides to take part in the study he/she will be required to sign the declaration of consent.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Copenhagen、丹麦、DK-2400
- Kirurgisk afdeling K, Bispebjerg Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients suffering from locally advanced pancreatic cancer and have started treatment with Folfirinox but must stop because of side effects or who declined the Folfirinox treatment.
- Minimum age of 18 years old and be capable of understanding the information and giving informed consent,
- Minimum height of 155 cm,
- Expected survival time (life expectancy) of over 6 months,
- Adequate performance status £ 2 (see below*),
Exclusion Criteria:
- Evident signs of distant metastasis at baseline
- Positive tests for anti-HIV-1/2; HBsAg, anti-HBc, Anti-HCV or being positive in a Treponema Pallidum test (syphilis),
- Patient´s which have visit an area where there is an outbreak of West Nile virus or Dengue virus within 28 days prior to donation should be excluded, unless the patient has been tested negative,
- Concurrent illness, e.g. uncontrolled epilepsy, cardiovascular-, cerebrovascular-, and/or respiratory disease which can worsen or cause complications in connection with blood donation,
- Clinically significant autoimmune disorders or conditions of immune suppression,
- Haemoglobin count ≤ 7.5 mmol/l (men & women),
- Lymphocytes below 0.3 x 109/l,
- Clinically abnormal Erythrocyte Volume Fraction (EVF),
- Body weight below 40 kg (men) and 50 kg (women),
- Pregnant or breast feeding women. Fertile women can only be included with a negative pregnancy test at screening and must use contraceptives during the study,
- Patients with uncontrolled serious bacterial, viral, fungal or parasitic infection,
- Blood transfusions within 48 hours prior to donation of blood for ALECSAT production,
- Any medical condition that will render participation in the study risky or, according to the investigator will make the assessment of the study endpoints difficult,
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Alecsat
The ALECSAT CBMP will be administered as single dose at week 4, 7 and week 10 which is considered an appropriate time for ALECSAT CBMP to strengthen the immune system and thus have the ability to kill tumour cells.
It is the aim that the patients will receive three doses during the study period however, if the patient wish and it is recommended by the investigator, patients may receive more than three doses, continuing until progression or as judged by the Investigator.
Continued treatment after the 24 week study period is only possible under the condition that no safety issues have been discovered.
The interval between injections for continued treatment will be decided based on e.g.
tumour response and clinical examinations.
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The ALECSAT CBMP will be administered as single dose at week 4, 7 and week 10 which is considered an appropriate time for ALECSAT CBMP to strengthen the immune system and thus have the ability to kill tumour cells.
It is the aim that the patients will receive three doses during the study period however, if the patient wish and it is recommended by the investigator, patients may receive more than three doses, continuing until progression or as judged by the Investigator.
Continued treatment after the 24 week study period is only possible under the condition that no safety issues have been discovered.
The interval between injections for continued treatment will be decided based on e.g.
tumour response and clinical examinations.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Safety and tolerability
大体时间：Up to 24 weeks
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Investigation of the safety and tolerability of administrating repeated doses of ALECSAT will be measured by recording the presence of adverse events/serious adverse events during the study period, and by following clinically significant changes in blood parameters, performance status and quality of life questionnaire at specific time points and compare with the individual patients status at baseline
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Up to 24 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Efficacy; Tumor change
大体时间：Up to 24 weeks
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Assessment of any change in tumour involvement are followed by CT (according to the RECIST 11 protocol) at specific time points and will be compared with the individual patients status at baseline
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Up to 24 weeks
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Efficacy; Lab parameters
大体时间：Up to 24 weeks
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Changes in pancreatic cancer marker CA19-9, change in Haemoglobin, Lymphocytes and their subpopulations, Leucocytes, ASAT, ALAT, Amylase, Bilirubin, Glucose, LDH, Sodium and Potassium that may show trends of clinical effect at specific time points and will be compared with the individual patients status at baseline,
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Up to 24 weeks
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Safety & efficacy; Quality of life
大体时间：Up to 24 weeks
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Changes in the patients quality of life and performance status are measured at specific time points and will be compared with the individual patients status at baseline,
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Up to 24 weeks
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合作者和调查者
赞助
调查人员
- 首席研究员：Lars T. Sørensen, MD、Bispebjerg Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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