Combination Vaccine Immunotherapy (DRibbles) for Patients With Definitively-Treated Stage III Non-small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT01909752 |
Recruitment Status
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Completed
First Posted
: July 26, 2013
Last Update Posted
: July 6, 2017
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Sponsor:
UbiVac
Collaborators:
National Cancer Institute (NCI)
Providence Cancer Center, Earle A. Chiles Research Institute
Providence Health & Services
Mayo Clinic
Louisiana State University Health Sciences Center in New Orleans
Information provided by (Responsible Party):
UbiVac
Tracking Information | ||||
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First Submitted Date ICMJE | July 24, 2013 | |||
First Posted Date ICMJE | July 26, 2013 | |||
Last Update Posted Date | July 6, 2017 | |||
Study Start Date ICMJE | July 2013 | |||
Actual Primary Completion Date | November 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Identify the regimen that produces the strongest antibody response [ Time Frame: 95 days ] 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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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01909752 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Combination Vaccine Immunotherapy (DRibbles) for Patients With Definitively-Treated Stage III Non-small Cell Lung Cancer | |||
Official Title ICMJE | 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 | |||
Brief Summary | 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. | |||
Detailed Description | This is an open-label, randomized study in which the first 33 patients will be assigned to receive the either:
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Carcinoma, Non-Small-Cell Lung | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
12 | |||
Original Estimated Enrollment ICMJE |
48 | |||
Actual Study Completion Date | April 2017 | |||
Actual Primary Completion Date | November 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01909752 | |||
Other Study ID Numbers ICMJE | UbiVac DPV-001 R44CA121612 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | UbiVac | |||
Study Sponsor ICMJE | UbiVac | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | UbiVac | |||
Verification Date | July 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |