Combination Vaccine Immunotherapy (DRibbles) for Patients With Definitively-Treated Stage III Non-small Cell Lung Cancer
2017年7月3日 更新者：UbiVac
Randomized Phase II Trial of Cyclophosphamide With Allogeneic Non-Small Cell Lung Cancer (NSCLC) DRibble Vaccine Alone or With Granulocyte-Macrophage Colony-Stimulating Factor or Imiquimod for Adjuvant Treatment of Definitively-Treated Stage IIIA or IIIB NSCLC
This study will test an investigational vaccine, called DRibbles, for the treatment of non-small cell lung cancer (NSCLC).
We hypothesize that vaccination with the DRibble vaccine will cause an immune responses against proteins contained in the DRibble vaccine and the protein antigens targeted by this strong immune response will include common antigens shared by both the vaccine and the patient's tumor.
研究概览
地位
完全的
条件
详细说明
This is an open-label, randomized study in which the first 33 patients will be assigned to receive the either:
- DRibbles vaccine and HPV vaccine
- DRibbles vaccine, HPV vaccine, and imiquimod
- DRibbles vaccine, HPV vaccine, and GM-CSF After 11 patients have been assigned to each group, the study arm with the greatest number of vaccine-induced strong antibody responses will then continue with enrollment of 15 further patients. The primary objective is to determine the best strategy to induce strong (>15 fold) tumor-specific or tumor-associated antibody responses in patients with stage III A and B NSCLC. The goal is to select one regimen to advance to additional clinical trials.
研究类型
介入性
注册 (实际的)
12
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Louisiana
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New Orleans、Louisiana、美国、70112
- LSU Stanley S. Scott Cancer Center
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Oregon
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Portland、Oregon、美国、97213
- Providence Cancer Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Stage IIIA or IIIB histologically proven non-small cell lung cancer
- Completion of definitive therapy
- Enrollment from 28 days to 12 weeks from completion of definitive therapy
- Toxicities from definitive therapy resolved to less than grade 1
- ECOG performance status 0-1
- Negative pregnancy test in women of childbearing potential
- Agree to avoid pregnancy or fathering a child while on study treatment
- Ability to give informed consent and comply with protocol
- Anticipated survival minimum of 6 months
- Prior therapy with investigational agents must be completed at least 3 weeks prior to study enrollment
- Normal organ and marrow function as defined by specific lab tests
- Archived tumor tissue available
Exclusion Criteria:
- Active autoimmune disease except for vitilogo or hypothyroidism
- Active other malignancy
- Known HIV+ and/or Hepatitis B or C positive
- Medical or psychiatric conditions that would preclude safe participation
- Ongoing chemotherapy
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 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：DRibble Vaccine Alone
Cyclophosphamide (300 mg/m2) will be administered as a single dose three days prior to beginning vaccine therapy.
DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19, 25, 31, 37, and 43.
Immunization with HPV vaccine intramuscular injection at the time of the first and third vaccinations.
|
Cyclophosphamide (300 mg/m2) will be administered as a single dose three days prior to beginning vaccine therapy.
其他名称：
DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19, 25, 31, 37, and 43.
Immunization with HPV vaccine will consist of two 0.5-mL intramuscular injection at the time of the first and third vaccinations.
The preferred site of administration is the deltoid region of the upper arm.
其他名称：
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实验性的：DRibble vaccine with imiquimod
Cyclophosphamide (300 mg/m2) will be administered as a single dose three days prior to beginning vaccine therapy.
DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19, 25, 31, 37, and 43.
Imiquimod cream (5%, 250 mg containing 12.5 mg imiquimod - one packet/day) will be self applied once per day starting with the second vaccine (week 4) and for four days following each vaccine cycle.
Immunization with HPV vaccine intramuscular injection at the time of the first and third vaccinations.
|
Cyclophosphamide (300 mg/m2) will be administered as a single dose three days prior to beginning vaccine therapy.
其他名称：
DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19, 25, 31, 37, and 43.
Immunization with HPV vaccine will consist of two 0.5-mL intramuscular injection at the time of the first and third vaccinations.
The preferred site of administration is the deltoid region of the upper arm.
其他名称：
Imiquimod cream (5%, 250 mg containing 12.5 mg imiquimod - one packet/day) will be self applied once per day starting with the second vaccine (week 4).
Immediately following vaccination and for four days following each vaccine cycle (total 5 days) imiquimod will be applied to a 4 x 5-cm outlined area of healthy extremity skin that includes the vaccine site.
其他名称：
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实验性的：DRibble vaccine with GM-CSF
Cyclophosphamide (300 mg/m2) will be administered as a single dose three days prior to beginning vaccine therapy.
DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19, 25, 31, 37, and 43.
GM-CSF will be administered at 50 mcg/day starting with the second vaccine (week 4) and continuing with each subsequent vaccine.
Immunization with HPV vaccine intramuscular injection at the time of the first and third vaccinations.
|
Cyclophosphamide (300 mg/m2) will be administered as a single dose three days prior to beginning vaccine therapy.
其他名称：
DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19, 25, 31, 37, and 43.
Immunization with HPV vaccine will consist of two 0.5-mL intramuscular injection at the time of the first and third vaccinations.
The preferred site of administration is the deltoid region of the upper arm.
其他名称：
GM-CSF will be administered at 50 mcg/day starting with the second vaccine (week 4) and continuing with each subsequent vaccine.
A volume of 0.2 cc will be delivered by the CADD-MSTM 3 Ambulatory infusion pump at a rate of 0.008 cc/hr.
The pump will be refilled after three days for a total of six days of infusion.
其他名称：
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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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Identify the regimen that produces the strongest antibody response
大体时间：95 days
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The best regimen will be defined as the one that generates the greatest increase in the number of strong antibody responses as defined by a greater than 15-fold increase in antibody, as measured using the Immune Response Biomarker Profiling Array (Invitrogen) on the day 95 serum sample.
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95 days
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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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Safety
大体时间：43 weeks
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To evaluate the overall safety of allogeneic NSCLC DRibble vaccine alone or in combination with either imiquimod or GM-CSF, as adjuvant treatment for definitively-treated patients with Stage IIIA or B NSCLC.
During the treatment period, patients will be seen in clinic 13 times over a 22-week period; performance status and side-effects will be evaluated at each visit.
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43 weeks
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无进展生存期
大体时间：2年
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评估无进展生存期。
通过 CT 扫描的肿瘤测量值将在第 16 周获得，随后由治疗研究者决定。
治疗期结束后，患者将每 3 个月接受一次检查，持续 2 年，或直至疾病进展。
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2年
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Immune response and progression-free survival correlation.
大体时间：2 years
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Evaluate whether any immune response data correlate with progression-free survival.
Immune response data will be collected 12 times over the first 43 weeks and then every 3 months until two years or progressive disease.
This data will be correlated with progression-free survival.
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2 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年7月1日
初级完成 (实际的)
2016年11月1日
研究完成 (实际的)
2017年4月1日
研究注册日期
首次提交
2013年7月24日
首先提交符合 QC 标准的
2013年7月24日
首次发布 (估计)
2013年7月26日
研究记录更新
最后更新发布 (实际的)
2017年7月6日
上次提交的符合 QC 标准的更新
2017年7月3日
最后验证
2017年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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