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

NCT01111292 | Terminated Phase 1 Results DMC

• 6 other identifiers: NCI-2011-01434CDR0000671302NCI09-13-02NWU09-13-02P30CA060553N01CN35157
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Colon Carcinoma; Dysplasia in Crohn Disease; Low Grade Dysplasia in Ulcerative Colitis; Rectal Carcinoma

Outcome Measures

Primary Outcomes (1)

• The Effect of Myo-inositol (Inositol) on P-β-catenin Staining in Areas of Low Grade Dysplasia in Subjects With Known Colitis-induced Low Grade Dysplasia.

  The primary objective of this study will be to evaluate the effect of myo-inositol (inositol), administered for three months, on P-β-catenin staining in areas of low grade dysplasia or in areas of prior low grade dysplasia in subjects with known colitis-induced low grade dysplasia at baseline.

  Baseline to 90 days

Study Arms (2)

Arm I (inositol)

EXPERIMENTAL

Beginning within 14 days after colonoscopy, patients receive inositol PO QD on days 1-14 and BID on days 15-90.

Drug: Inositol

Arm II (placebo)

PLACEBO COMPARATOR

Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days 1-14 and BID on days 15-90.

Other: Placebo

Interventions

Inositol DRUG

Given PO

Also known as: myo-Inositol

Arm I (inositol)

Placebo OTHER

Given PO

Also known as: PLCB

Arm II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (3)

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Interventions

Inositol

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Results Point of Contact

• Title: Dr. Seema Khan
• Organization: Northwestern University

SKhan@nm.org

(312) 503-4236

Study Officials

• Seema Khan

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2010
• First Posted: April 27, 2010
• Study Start: October 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: July 12, 2016
• Results First Posted: July 12, 2016

Record last verified: 2016-06

Locations

US (3)