Clinical Trial: Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Randomized, Double-Blind, Placebo-Controlled Trial of MUC1 Vaccine in Patients With Newly Diagnosed Advanced Adenomas

Brief 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.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To compare the immunogenicity at week 12 of a MUC1 peptide vaccine with adjuvant (MUC1 peptide-poly-ICLC adjuvant vaccine) (administered at 0, 2, and 10 weeks) in participants with a history of an advanced adenoma, randomized to receive MUC1 peptide vaccine versus placebo.

SECONDARY OBJECTIVES:

I. To evaluate the ability of the vaccine to elicit a long‐term memory response.

II. To compare the adenoma recurrence rate from surveillance exams occurring at least 1 year and up to 3 years after week 0 vaccine administration - MUC1 versus placebo.

III. To compare the adenoma recurrence rates between MUC1 and placebo by excluding the following types of adenomas: participants with adenomas =< 5 mm; participants with adenomatous tissue which may represent residual adenoma at the site of the previous advanced adenoma; participants with adenomatous tissue detected in the same segment of the bowel as the previous advanced adenoma.

IV. To assess adverse events to the MUC1 peptide vaccine in comparison to placebo during Parts I and II.

V. To assess patient reported injection site reaction events from the Vaccine Report Card.

TERTIARY OBJECTIVES:

I. To compare the anti‐MUC1 antibody titer at the time of surveillance colonoscopy for the purpose of evaluating the anti‐MUC1 antibody response in relation to adenoma recurrence.

II. To evaluate MUC1 expression on baseline advanced adenomas and on recurrent ad
Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Change in anti-MUC1 immunoglobulin G (IgG) levels as determined by enzyme-linked immunosorbent assay (ELISA) [ Time Frame: Week 0 to week 12 ]

The ratio of the week 12 to week 0 IgG levels will be calculated and compared between the MUC1 vaccine and placebo. The Wilcoxon Rank‐Sum test will be used. For all measurements of response (i.e. the primary endpoint), the 95% confidence intervals will also be provided.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Adenoma recurrence rate assessed using surveillance exams [ Time Frame: Up to 3 years ]
  • Booster response [ Time Frame: At week 55 ]
    The key secondary endpoint for Part 2 will assess the booster response at week 55 vs. week 52 for the vaccine as compared to placebo.
  • Incidence of adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 57 weeks ]
    The maximum grade for each type of adverse event will be recorded for each participant and frequency tables will be reviewed to determine the overall patterns. The number and severity of adverse events (overall and by arm) will be tabulated and summarized across all grades. Grade 3+ adverse events will be similarly described and summarized separately. Frequency distributions, graphical techniques, and other descriptive measures will form the basis of these analyses.
  • Incidence of participant-reported injection site reaction collected using the participant completed Vaccine Report Card [ Time Frame: Up to 57 weeks ]
    Descriptive statistics will be used to summarize these data and compare the data between study arms.
  • Proportion of patients with at least a 2‐fold increase in the IgG ratio [ Time Frame: At 12 weeks ]


Original Secondary Outcome:

  • Proportion of patients with at least a 2‐fold increase in the IgG ratio [ Time Frame: At 12 weeks ]
  • Booster response [ Time Frame: At week 55 ]
  • Booster response [ Time Frame: At week 52 ]
  • Adenoma recurrence rate assessed using surveillance exams [ Time Frame: Up to 3 years ]
  • Incidence of adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 57 weeks ]
    The maximum grade for each type of adverse event will be recorded for each participant and frequency tables will be reviewed to determine the overall patterns. The number and severity of adverse events (overall and by arm) will be tabulated and summarized across all grades. Grade 3+ adverse events will be similarly described and summarized separately. Frequency distributions, graphical techniques, and other descriptive measures will form the basis of these analyses.
  • Incidence of participant-reported injection site reaction collected using the participant completed Vaccine Report Card [ Time Frame: Up to 57 weeks ]
    Descriptive statistics will be used to summarize these data and compare the data between study arms.


Information By: National Cancer Institute (NCI)

Dates:
Date Received: May 7, 2014
Date Started: June 2014
Date Completion:
Last Updated: March 13, 2017
Last Verified: March 2017