BENITIONSClinical Trial Intelligence

Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps

Фаза 2 Идёт, набор закрыт NCT02134925

ЗаболеваниеColorectal Adenoma, Colorectal Carcinoma, Colorectal Conventional Adenoma With Severe Dysplasia, Colorectal Tubulovillous Adenoma
ФазаФаза 2
СпонсорNational Cancer Institute (NCI)
СтатусИдёт, набор закрыт
Участники110 участн.
ВмешательствоLaboratory Biomarker Analysis, MUC1 Peptide-Poly-ICLC Vaccine, Quality-of-Life Assessment, Saline
Дата начала23.06.2014
Дата завершения27.01.2017
Публикация результатов18.05.2018

Кратко

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
Arm II (Placebo)1.0 IgG ratio
p-value0.0004

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