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Cancer Vaccine

MUC1 Poly-ICLC for Colorectal Cancer

Phase 2
Waitlist Available
Led By Robert E Schoen
Research Sponsored by Robert Schoen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 54 weeks
Awards & highlights
No Placebo-Only Group

Summary

The purpose of this study is to evaluate the immune response to MUC1 - poly-ICLC vaccine, an investigational or study vaccine. The MUC1 - poly-ICLC vaccine is being tested in persons with a history of advanced adenomatous polyps, the precursor to colorectal cancer. The MUC1 - poly-ICLC vaccine is being developed to prevent polyps from advancing into colon cancer and to prevent polyps from recurring. MUC1 is mucus that is normally present on the lining of the human colon. However, MUC1 is expressed in a larger amount and in a modified form on adenomatous polyps and colorectal cancer. These changes in MUC1 are thought to be part of the process of progression from adenomas toward cancer. The goal of a vaccine is to help the immune system in the body identify the changes in MUC1 that accompany the progression to cancer and eliminate the abnormal cells that make abnormal MUC1.

Eligible Conditions
  • Colorectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~54 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 54 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Anti Muc-1 Antibody
Secondary study objectives
Number of Participants With Adverse Events Associated With the Study Agent
Number of Participants With Autoimmune Response to Muc-1 Vaccine

Side effects data

From 2012 Phase 2 trial • 46 Patients • NCT00773097
100%
injection site discomfort/ reddness
8%
Fatigue
8%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
MUC1 Poly-ICLC

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: MUC1 Poly-ICLCExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MUC1 - Poly ICLC
2008
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Robert SchoenLead Sponsor
National Cancer Institute (NCI)NIH
13,868 Previous Clinical Trials
41,010,791 Total Patients Enrolled
Robert E SchoenPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
110 Total Patients Enrolled
~3 spots leftby Oct 2025