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 States110 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 range40 Years – 70 Years
SexALL
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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…
What they're measuring
1
Change in Anti-MUC1 Immunoglobulin G (IgG) Levels as Determined by Enzyme-linked Immunosorbent Assay (ELISA)