Background on Colorectal Cancer Clinical Trials in the US

• In the US, there are 2143 clinical trials that have been completed, are about to begin, or are currently in progress, according to the government clinical trials database. Of these, there are 693 that are currently active, recruiting (or will be soon), or enrolling by invitation.
• There are a number of different types of studies going on in every state, with Texas offering the largest selection with 223 current studies and California offering the second largest selection at 207.
• In drilling down further, in Texas, for example, 184 of the 223 trials in progress are active and registering only adults (ages 18 – 65+). Notably, not all of these studies are non-invasive or involve immune system-based interventions. An example study from one of the institutions studying immune system-based non-invasive interventions in Texas is detailed below, along with other studies in other states by other institutions.

University of Texas Southwestern Medical Center

• Total number of colorectal cancer treatment clinical trials in progress: 18 
• Example Trial: “Geographically Clustered Mailing of Fecal Immunochemical Test (FIT) Kits” – Non-phased trial that began in Aug 2018 and runs through Aug 2021, led by Sandi Pruitt PhD (principal investigator). Sponsors and collaborators are the Cancer Prevention Research Institute of Texas and Parkland Health & Hospital System. The study seeks to identify the feasibility of mailing fecal test kits (to help identify early signs of colorectal cancer) to all relevant populations within a specific zip code range as a health screening strategy. Further details can be found here.

National Institutes of Health Clinical Center

• Total number of colorectal cancer treatment clinical trials in progress: 13 
• Example Trial: “A Phase I / Phase II Study of Pexa-Vec Oncolytic Virus in Combination with Immune Checkpoint inhibition in Refractory Colorectal Cancer” – Phase I/II trial that began this month (Dec 2019) and runs until Dec 2021. It is sponsored by the National Cancer Institutes (NCI), and has two primary contacts listed - Donna M Hrones, C.R.N.P. (contact) and Tim F. Greten M.D. (principal investigator). The purpose of this study is to “safety, tolerability and feasibility of Pexa-Vec oncolytic virus in combination with immune checkpoint inhibition in patients with refractory metastatic colorectal cancer,” and it will include the participants to be dosed (at one of two dose levels) with the Pexa-Vac oncolytic virus. Further details can be found here.

Dana-Farber Cancer Institute

• Total number of colorectal cancer treatment clinical trials in progress: 100+ 
• Example Trial: “Study to Identify Transcriptional Targets of Vitamin D in Patients with Stage I – III Colon Cancer or Resectable Colon Cancer Liver Metastases Receiving Preoperative Vitamin D Supplementation” – Early Phase I study that is currently recruiting for study participants. It is sponsored by the National Cancer Institute and Pharmavite LLC, with the responsible party being noted as Kimmie Ng, MD. The purpose of the study is to increase knowledge of how the vitamin D receptors work in colon cancer cells to identify if targeting the vitamin would be useful for those about to undergo (or having already undergone) colorectal cancer surgery. The study is about the vitamin’s effect, not the surgery, so this was considered to be “non-invasive;” the study related to vitamins and the body’s reactions to doses of the same, so this was considered related to immune system functioning. Further details can be found here.