A Phase 2 interventional study of MUC1 - Poly ICLC in Risk for Colorectal Cancer, sponsored by Robert Schoen. Completed at 1 site in United States. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-01-07.
Sponsored by Robert Schoen · Phase 2, Interventional, and Prevention
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.
This is a phase II trial designed to assess antibody and T cell responses to MUC1 vaccine among subjects at increased risk for colorectal cancer by virtue of a history of advanced adenoma. The primary objective is to evaluate the immunogenicity of a combination of the 100mer MUC1 peptide and adjuvant Poly-ICLC in boosting the immune response to MUC1. Among the secondary objectives is to determine if anti-MUC1 immunity, preexisting or vaccine induced, has an effect on the recurrence of polyps. Subjects with a history of advanced adenoma will be recruited for MUC1 vaccination. Vaccine will be administered at weeks 0, 2, and 10. Some subjects may have pre-existing immunity to MUC1, and this will be accounted for in the analytic phase. However, all subjects will be administered the vaccine, regardless of baseline antibody status. To insure accurate standardization in measurement and assessment of antibody levels, assays for baseline antibody status will be done at the same time as those for response to vaccine.
5,738 studies on the registry are indexed under Colorectal Neoplasms; 1,483 are open to participants now.
This study's enrollment of 46 is below the median of 77 across 4,226 interventional studies indexed under Colorectal Neoplasms.
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-Age 40 - 70 years of age.
History of any of the following conditions (operative notes, endoscopy reports, and/or pathology reports must be reviewed locally to confirm that the candidate meets at least one of the following entry criteria).
Exclusion Criteria:
Biological: MUC1 - Poly ICLC
The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
Number of Participants With Anti Muc-1 Antibody
Evaluation of the immune response to MUC1 peptide vaccine administered with Poly-ICLC, measured by Anti MUC1 antibody, in patients with a history of advanced colorectal adenoma.
Time frame: 52 weeks
Number of Participants With Autoimmune Response to Muc-1 Vaccine
Evaluate for autoimmune response by measuring the Anti-muc-1 IgG antibodies to the muc-1 vaccine.
Time frame: 52 weeks
Number of Participants With Adverse Events Associated With the Study Agent
Laboratory monitoring including Toxicity laboratory test or monitored through out the study up to week 54.
Time frame: 54 weeks
Patient recruitment took place at the University of Pittsburgh Digestive Disorders Clinic. Start date for enrollment was November 11, 2008 - February 16, 2011
| Milestone | MUC1 Poly-ICLC |
|---|---|
| Started | 46 |
| Completed | 39 |
| Not completed | 7 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Physician decision | 6 |
Evaluation of the immune response to MUC1 peptide vaccine administered with Poly-ICLC, measured by Anti MUC1 antibody, in patients with a history of advanced colorectal adenoma.
| participants | MUC1 Poly-ICLC |
|---|---|
| Number of Participants With Anti Muc-1 Antibody | 39 |
Evaluate for autoimmune response by measuring the Anti-muc-1 IgG antibodies to the muc-1 vaccine.
| participants | MUC1 Poly-ICLC |
|---|---|
| Number of Participants With Autoimmune Response to Muc-1 Vaccine | 39 |
Laboratory monitoring including Toxicity laboratory test or monitored through out the study up to week 54.
| participants | MUC1 Poly-ICLC |
|---|---|
| Number of Participants With Adverse Events Associated With the Study Agent | 39 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MUC1 Poly-ICLC | — | 0/39 (0%) | 39/39 (100%) |
| Event | MUC1 Poly-ICLC |
|---|---|
| injection site discomfort/ reddnessSkin and subcutaneous tissue disorders | 39/39 |
| FatigueImmune system disorders | 3/39 |
| HeadacheGeneral disorders | 3/39 |
A total of 39 subjects completed the 52 weeks of the study.
| Age, Categorical(Participants) | MUC1 Poly-ICLC |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 39 |
| >=65 years | 7 |
| Sex: Female, Male(Participants) | MUC1 Poly-ICLC |
|---|---|
| Female | 21 |
| Male | 25 |
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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