National Cancer Institute (NCI)
The purpose of this phase I trial is to test the safety and cancer preventive effects of different doses of ONC201 in people with familial adenomatous polyposis (FAP) or a history of multiple polyps. People with familial adenomatous polyposis (FAP) or a history of multiple polyps are at higher than average risk of developing colorectal cancer. ONC201, now known as dordaviprone, is a drug that may stop cancer cells from growing. This drug has been shown in previous studies to cause cancer cell death but not harm normal cells. If successful, this study may help us develop a new option for colorectal cancer prevention.
PRIMARY OBJECTIVE: I. To evaluate the safety and toxicity of dordaviprone (ONC201) for the indication of cancer prevention in a healthy population of individuals who are at high risk (FAP and/or history of multiple adenomas \[excluding hereditary nonpolyposis colorectal cancer (HNPCC)\]) for recurrent colorectal adenomas. SECONDARY OBJECTIVES: I. To determine the dose(s) of ONC201 that yield(s) a statistically significant increase in human adenoma tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) expression. II. To determine the dose(s) of ONC201 that yield(s) a statistically…
Inclusion Criteria: * Be identified as high risk for recurrent colorectal adenomas, as defined by: * A diagnosis of FAP AND/OR * Findings of either \> 5 small (less than 1 cm) adenomas OR \>= 3 with at least one \>= 10 mm on most recent colonoscopy performed in the past 5 years * Be \>= 18 years of age on day of signing informed consent * Have an Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%) * Leukocytes \>= 3,000/microliter * Absolute neutrophil count \>= 1,000/microliter * Platelets \>= 100,000/microliter * Total bilirubin within normal institut…
Undergo biopsy
Undergo collection of blood
Undergo colonoscopy
Given PO
Ancillary studies
Undergo sigmoidoscopy