Testing A Combination Of Vaccines For Cancer Prevention In Lynch Syndrome
Lynch Syndrome Vaccine Study
About the Study
(LS) increases the risk of colon cancer and other cancers, including cancer of the uterus, ovaries, small bowel, stomach, pancreas, urinary tract, skin, and brain.
This study is being done to assess the safety and effectiveness of a series of vaccines (Tri-Ad5), together with another drug (N-803) that magnifies the body’s response to vaccines, to see if there is an effect on the risk of developing colon and other cancers in LS patients.
For more Information, visit https://bit.ly/ihavelynch
What the Study Entails
If you consent and are eligible to join this trial, you will attend a total of 8 study appointments. During these visits you will receive a series of injections (3-4 injections four times over a one-year period) and undergo yearly colonoscopies as part of routine care. You can also expect physical exams, blood draws, review of your medical history, and completion of questionnaires and a vaccine report card to report any injection side effects.
Site: University of Kansas Medical Center, Kansas City, KS
Protocol and Site Principal Investigator: Ajay Bansal, MD
Site: University of Texas MD Anderson Cancer Center, Houston, TX
Protocol and Site Principal Investigator: Eduardo Vilar-Sanchez, MD, PhD
Site: Northwestern University, Chicago, IL
Investigator: Mohammad Abbass, MD
Site: Cleveland Clinic, Cleveland, OH
Investigator: Carol Burke, MD
Site: University of Puerto Rico, San Juan, Puerto Rico
Investigator: Marcia R. Cruz-Correa, M.D., Ph.D., AGAF, FASGE
Site: Ohio State University, Columbus, OH
Investigator: Peter Stanich, MD
Site: Mayo Clinic Rochester, Rochester, MN
Investigator: Lisa Boardman, MD
Site: Dana-Farber Cancer Institute, Boston, MA
Investigator: Ramona Lim, MD
Site: University of Colorado, Aurora, CO
Investigator: Swati G. Patel, MD, MS
Site: Mayo Clinic at Arizona, Phoenix, AZ
Investigator: Niloy Jewel Samadder, MD, MSc, FRCPC
Site: University of Arizona Cancer Center, Tucson, AZ
Investigator: Aaron James Scott, MD
Site: University of Michigan, Ann Arbor, MI
Investigator: Elena Stoffel, MD, MPH
Site: University of California San Francisco Medical Center
Investigator: Aparajita Singh, MD, MPH
Study Lead Investigators
Ajay Bansal, MD
University of Kansas Medical Center
Eduardo Vilar-Sanchez, MD, PhD
University of Texas MD Anderson Cancer Center
People 18 years or older who:
- Have been diagnosed with and have had abnormal growths in their colon or rectum.
- Have not had any cancer treatment in the past 6 months.
- Are not pregnant or planning to get pregnant.
People who do not meet the eligibility criteria defined above and those who:
- Have experienced severe side effects or allergic reations to previous vaccines.
- Have a blood clotting disorder.
- Have had organ transplants.
- Are pregnant or breastfeeding.