Inositol in Preventing Colorectal Cancer in Patients With Colitis-Associated Dysplasia

• Status: Terminated
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This pilot, randomized phase I/II trial studies how well inositol works in preventing colorectal cancer in patients with abnormal cells (dysplasia) associated with inflammation of the colon (colitis). Patients with colitis-associated dysplasia may have an increased risk of developing colorectal cancer. Inositol is a vitamin-like substance that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Inositol

Criteria

Inclusion Criteria:

• Participants must have ulcerative colitis or Crohn's disease with low grade dysplasia or polyploid dysplasia or have a history of dysplasia and increased positive beta-catenin levels confirmed by a consensus of the study pathologists (2 of 2, or 2 of 3)

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

• Absolute neutrophil count (ANC) > 1,500/uL

• Platelets > 100,000/uL

• Total bilirubin within normal institutional limits

• Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT] =< 1.5 times upper limit of normal

• Creatinine within normal institutional limits

• International normalized ratio (INR) < 1.5

• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time of baseline pregnancy test, throughout the duration of the study, and for 1 month following cessation of study drug; females must begin adequate contraception immediately following screening pregnancy test; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately; if she is pregnant, she will be immediately withdrawn from the study and followed until the birth of the child

• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Subjects with life-threatening medical conditions that would preclude study treatment intervention and colonoscopy

• Participants may not be receiving any other investigational agents

• History of allergic reactions to rice or compounds of similar chemical or biologic composition to myo-inositol (i.e., urticaria, dermatologic reaction)

• Use of medications known to elevate serum blood glucose; participants on steroids are still eligible, as they will be monitored weekly for fasting blood glucose

• Participants with dysplasia-associated lesion or mass (DALM), high-grade dysplasia or invasive colonic carcinoma are excluded

• Uncontrolled intercurrent illness including, but not limited to

• Ongoing or active infection

• Symptomatic congestive heart failure

• Unstable angina pectoris

• Cardiac arrhythmia

• Chronic renal failure

• Chronic renal insufficiency

• Psychiatric illness or social situations that would limit compliance with study requirements

• Prior treatment with myo-inositol

• History of systemic chemotherapy within 18 months of screening

• Subjects taking valproic acid and/or lithium

• Diabetes mellitus

• History of total proctocolectomy

• Concomitant primary sclerosing cholangitis (PSC)

• Pregnant or lactating subjects are excluded