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NCT01519817 · ClinicalTrials.gov registry record · Phase 1
Cancer Vaccine Targeting Brachyury Protein in Tumors
A Phase 1 study of Neoplasms and Adenocarcinoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT01519817: Completed Phase 1 study of Neoplasms and Adenocarcinoma, sponsored by National Cancer Institute (NCI).
NCT01519817 is a Phase 1 study of Neoplasms and Adenocarcinoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 34 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01519817, a Phase 1 study of Neoplasms and Adenocarcinoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- Cancer vaccines are being developed to help teach the body's immune system to attack and destroy cancer cells. A new vaccine being tested targets Brachyury protein. This protein is present in some tumor cells, and it can help tumor cells spread to other parts of the body. Researchers want to see whether the new Brachyury protein vaccine can help treat people with advanced carcinomas. Objectives: \- To test the safety and effectiveness of a cancer vaccine that targets Brachyury protein in tumor cells. Eligibility: * Individuals at least 18 years of age who have advanced cancers that have not responded or are no longer responding to standard treatments. * Because the vaccine is made with yeast, people with yeast allergies will not be eligible. Design: * Participants will be screened with a medical history and physical exam. Imaging studies will be used to examine the cancer. Heart and thyroid function tests will be conducted. Blood and urine samples will also be collected. * Participants will receive vaccine injections every 2 weeks, for a total of seven visits. After seven visits, if the cancer has shrunk or stopped growing, participants will continue to have the vaccine about once a month. * Treatment will be monitored with frequent blood tests and imaging studies. Other tests will be given as directed by the study doctors. Some participants will have apheresis to collect additional blood cells for study. * Participants will continue to receive the vaccine as long the tumor does not start growing again and there are no serious side effects....
Primary Outcome
A fluorescense activated cell sorting (FACS)-based assay for cluster of differentiation 4 (CD4) or cluster of differentiation 8 (CD8) T-cells expressing the cytokines interferon (IFN) gamma, interleukin 2 (IL2), and tumor necrosis factor (TNF) alpha, and/or cluster of differentiation 107a (CD107a) (a marker for lytic potential) was used to determine the numbers of participants showing development or enhancement of the level of brachyury-specific T-cells after vaccination.
Conditions Studied
Interventions
- BIOLOGICAL GI-6301 (Yeast Brachyury Vaccine)
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2012-01-05 |
| Est. Completion | 2016-09-01 |
| Phase | Phase 1 |
What the finished NCT01519817 record still lists
NCT01519817 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (98% lower).
The record links to 4 conditions, with Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which GI-6301 (Yeast Brachyury Vaccine) is the first listed.
NCT01519817 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01519817 about?
NCT01519817 is a clinical study titled "Cancer Vaccine Targeting Brachyury Protein in Tumors". Background: \- Cancer vaccines are being developed to help teach the body's immune system to attack and destroy cancer cells. A new vaccine being tested targets Brachyury protein. This protein is present in some tumor cells, and it can help tumor cells spread to other parts of the body. Researchers...
What is the current status of trial NCT01519817?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2012-01-05. Estimated completion is 2016-09-01.
What conditions does trial NCT01519817 study?
This clinical trial studies the following conditions: Neoplasms, Adenocarcinoma, Malignant Solid Tumors, Colon Neoplasms.
What interventions are being tested in trial NCT01519817?
The interventions under investigation include: GI-6301 (Yeast Brachyury Vaccine) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01519817?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01519817 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01519817's enrollment target sits among peer trials
34 127th of 158 higher than 31 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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