Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps (NCT02134925) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps
United States, Puerto Rico110 participantsStarted 2014-06-23
Plain-language 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.
Who can participate
Age range
40 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* History of at least one of the following conditions in the previous 12 months:
* Colorectal adenoma(s) \>= 1 cm in maximal diameter
* Colorectal adenoma(s) with villous or tubulovillous histology
* Colorectal adenoma(s) with high grade (severe) dysplasia
* Presumptive evidence that all adenomatous lesions, including qualifying advanced adenoma, have been completely removed
* Ability to understand and the willingness to sign a written informed consent document
* Willingness to undergo screening tests and procedures
* Willingness to provide blood samples for toxicity monitoring and research purposes
* Not pregnant or nursing; note: a negative (serum or urine) pregnancy test must be documented =\< 7 days prior to registration/randomization for women of childbearing potential
* Willingness to employ adequate contraception through week 53 of the study; note: women of childbearing potential and men must agree to use adequate contraception (hormonal, barrier method of birth control, abstinence) prior to study entry and for the period of active vaccination (through week 53); should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her physician immediately
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%)
* Hemoglobin greater than 90% of the lower limit of institutional normal
* Platelets \>= 100 B/L (10\^9/L)
* White blood cell (WBC) \> 2.5 B/L (10\^9/L)
* Aspar…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Anti-MUC1 Immunoglobulin G (IgG) Levels as Determined by Enzyme-linked Immunosorbent Assay (ELISA)