Vaccine Therapy for Advanced Colon Polyps

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Immunomodulators, Oral corticosteroids

Disqualifiers: Colorectal cancer, Other malignancy, Autoimmune diseases, others

Stay on Your Current Meds You can continue your current medications while participating

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

Duration: 55 weeks

110 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial requires that you do not use certain medications, like immunomodulators (drugs that affect the immune system) and oral corticosteroids, before and during the study. If you are taking these, you may need to stop them before joining the trial.

What data supports the effectiveness of the MUC1 Peptide-Poly-ICLC Vaccine treatment for advanced colon polyps?

Research shows that MUC1-based vaccines can trigger strong immune responses against colon cancer cells, reducing tumor growth and preventing recurrence in preclinical models. Additionally, MUC1 vaccines have been effective in generating immune responses in other cancer types, suggesting potential benefits for treating advanced colon polyps. ^{1 2 3 4 5}

Is the MUC1 Peptide-Poly-ICLC Vaccine safe for humans?

Initial evaluations of MUC1 peptide vaccines have shown them to be safe and capable of inducing an immune response, although strong anti-tumor responses are rare. ^{1 2 6 7 8}

How is the MUC1 Peptide-Poly-ICLC Vaccine treatment different from other treatments for advanced colon polyps?

The MUC1 Peptide-Poly-ICLC Vaccine is unique because it aims to stimulate the immune system to recognize and attack cells expressing the MUC1 protein, which is often overexpressed in colon polyps and cancers. This approach is different from traditional treatments as it uses the body's own immune response to prevent or reduce tumor growth, potentially offering a preventive strategy for those at high risk. ^{1 2 6 7 9}

What is the purpose of this trial?

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.

Research Team

Robert E Schoen

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults with newly diagnosed advanced colon polyps at least 1 cm in size, with severe dysplasia or certain histologies, and all lesions must be removed prior to the study. Participants need normal organ function tests, not pregnant/nursing, willing to use contraception and provide blood samples. Excluded are those with any colorectal cancer history within 5 years (except some skin cancers), autoimmune diseases, uncontrolled illnesses, or using immunomodulators.

Inclusion Criteria

Hemoglobin greater than 90% of the lower limit of institutional normal

Platelets >= 100 B/L (10^9/L)

Alkaline phosphatase =< 1.5 x institutional upper limit of normal

Exclusion Criteria

I have been diagnosed with NASH and my liver disease score is 5 or higher.

I haven't taken oral steroids in the last 12 weeks.

I haven't had any cancer except for skin cancer in the last 5 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MUC1 peptide-poly-ICLC adjuvant vaccine or placebo subcutaneously at weeks 0, 2, and 10, with a booster injection at week 53

55 weeks

4 visits (in-person)

Follow-up

Participants are monitored for adenoma recurrence and safety every 6 months

Up to 3 years

6 visits (in-person)

Treatment Details

Interventions

• MUC1 Peptide-Poly-ICLC Vaccine

Trial Overview The trial is testing a vaccine therapy called MUC1 peptide-poly-ICLC adjuvant vaccine on patients with advanced colon polyps to see if it can prevent these polyps from turning into colorectal cancer by boosting the body's immune response against them. It also aims to prevent recurrence of polyps.

Participant Groups

Group I: Arm I (MUC1 peptide-poly-ILCLC adjuvant vaccine) Experimental Treatment 3 Interventions

Participants receive MUC1 peptide-poly-ICLC adjuvant vaccine SC in weeks 0, 2 and 10 and a booster injection in week 53.

Group II: Arm II (saline) Placebo Group 3 Interventions

Participants receive saline SC in weeks 0, 2, and 10 and a booster injection in week 53.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Findings from Research

The WT1/MUC1 dendritic cell vaccination was found to be safe and well-tolerated in 10 patients with surgically resectable pancreatic ductal adenocarcinoma, with no significant toxicities reported.

Preliminary results showed promising overall survival rates at 3 years (77.8%) and a potential link between the vaccination and increased immune response in tumor tissues, suggesting further investigation is needed to assess its clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dendritic Cell-based Immunotherapy Pulsed With Wilms Tumor 1 Peptide and Mucin 1 as an Adjuvant Therapy for Pancreatic Ductal Adenocarcinoma After Curative Resection: A Phase I/IIa Clinical Trial. Nagai, K., Adachi, T., Harada, H., et al.[2022]

The study demonstrates that MUC1 is essential for the effectiveness of colorectal cancer stem cell (CCSC) vaccines, as MUC1 knockdown reduced the vaccine's anti-tumor efficacy, while MUC1 overexpression enhanced it.

CCSC vaccines significantly reduced tumor growth by targeting CCSCs, increasing the activity of immune cells like NK cells, and promoting the release of key immune factors, indicating a robust immune response against colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colorectal cancer stem cell vaccine with high expression of MUC1 serves as a novel prophylactic vaccine for colorectal cancer. Guo, M., Luo, B., Pan, M., et al.[2021]

MUC1 is a protein that, when overexpressed and improperly modified, can trigger immune responses that may help improve survival rates in various cancers, including breast and pancreatic cancers.

Initial studies of MUC1-based vaccines have shown them to be safe and capable of inducing immune responses, suggesting they could be effective in preventing cancer recurrence and enhancing immune surveillance in high-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Natural and Induced Humoral Responses to MUC1. Von Mensdorff-Pouilly, S., Moreno, M., Verheijen, RH.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Randomized, Double-Blind, Placebo-Controlled Trial of MUC1 Peptide Vaccine for Prevention of Recurrent Colorectal Adenoma. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

MUC1-specific immune therapy generates a strong anti-tumor response in a MUC1-tolerant colon cancer model. [2018]

3. Greece pubmed.ncbi.nlm.nih.gov

Dendritic Cell-based Immunotherapy Pulsed With Wilms Tumor 1 Peptide and Mucin 1 as an Adjuvant Therapy for Pancreatic Ductal Adenocarcinoma After Curative Resection: A Phase I/IIa Clinical Trial. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Colorectal cancer stem cell vaccine with high expression of MUC1 serves as a novel prophylactic vaccine for colorectal cancer. [2021]

5. Greece pubmed.ncbi.nlm.nih.gov

Review. Colon cancer vaccines: an update. [2010]

6. Greece pubmed.ncbi.nlm.nih.gov

MUC1 peptide vaccination in patients with advanced pancreas or biliary tract cancer. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Natural and Induced Humoral Responses to MUC1. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Prevention of colitis-associated colon cancer using a vaccine to target abnormal expression of the MUC1 tumor antigen. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Cytotoxic T cell responses are enhanced by antigen design involving the presentation of MUC1 peptide on cholera toxin B subunit. [2018]