Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps
Phase 2
Active, not recruiting
NCT02134925
| Condition | Colorectal Adenoma, Colorectal Carcinoma, Colorectal Conventional Adenoma With Severe Dysplasia, Colorectal Tubulovillous Adenoma |
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| Phase | Phase 2 |
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| Sponsor | National Cancer Institute (NCI) |
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| Status | Active, not recruiting |
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| Enrollment | 110 participants |
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| Interventions | Laboratory Biomarker Analysis, MUC1 Peptide-Poly-ICLC Vaccine, Quality-of-Life Assessment, Saline |
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| Start date | Jun 23, 2014 |
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| Completion date | Jan 27, 2017 |
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| Results posted | May 18, 2018 |
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Summary
This randomized phase II clinical trial studies how well MUC1 peptide-poly-ICLC adjuvant vaccine works in treating patients with newly diagnosed advanced colon polyps (adenomatous polyps). Adenomatous polyps are growths in the colon that may develop into colorectal cancer over time. Vaccines made from peptides may help the body build an effective immune response to kill polyp cells. MUC1 peptide-poly-ICLC adjuvant vaccine may also prevent the recurrence of adenomatous polyps and may prevent the development of colorectal cancer.
Change in Anti-MUC1 Immunoglobulin G (IgG) Levels as Determined by Enzyme-linked Immunosorbent Assay (ELISA)
Week 0 to week 12 · IgG ratio
| Arm I (MUC1 Peptide-poly-ICLC Adjuvant Vaccine) | 1.2 IgG ratio |
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| Arm II (Placebo) | 1.0 IgG ratio |
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Open in BENITIONS
View on ClinicalTrials.gov
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