Niclosamide in Treating Patients with Colon Cancer That Can Be Removed by Surgery

Status: Active

Description

This phase I trial studies the side effects of niclosamide in treating patients with colon cancer that can be removed by surgery. Niclosamide may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Eligibility Criteria

Inclusion Criteria

  • Histologically confirmed diagnosis of colon or rectal adenocarcinoma of any clinical stage, previously untreated with chemotherapy or radiotherapy, with a plan to undergo surgical resection no sooner than 7 days from the projected date of study drug initiation
  • Karnofsky performance status greater than or equal to 70%
  • Absolute neutrophil count (ANC) >= 1500/mL
  • Hemoglobin >= 9 g/dL (may transfuse or use erythropoietin to achieve this level)
  • Platelets >= 100,000/mL
  • International normalized ratio (INR) < 1.5
  • Partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN)
  • Serum creatinine < 1.5 mg/dL
  • Bilirubin < 1.5 mg/dL (except for Gilbert’s syndrome which will allow bilirubin =< 2.0 mg/dL)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN
  • Ability to understand and provide signed informed consent that fulfills Institutional Review Board (IRB) guidelines
  • Ability to return to Duke University Medical Center for adequate follow-up, as required by this protocol

Exclusion Criteria

  • Patients with concurrent cytotoxic chemotherapy or radiation therapy
  • Known active brain or leptomeningeal metastases (defined as symptomatic metastases) or continued requirement for glucocorticoids for brain or leptomeningeal metastases; treated, asymptomatic metastases are permitted provided the patient has been off steroids for at least 4 weeks prior to day 1 of study drug
  • Serious intercurrent chronic or acute illness, such as cardiac disease (New York Heart Association [NYHA] class III or IV), hepatic disease, or other illness considered by the principal investigator as unwarranted high risk for investigational drug treatment
  • Patients with a medical or psychological impediment to probable compliance with the protocol should be excluded
  • Concurrent (or within the last 5 years) second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, controlled superficial bladder cancer, or other carcinoma in situ that has been treated
  • Known active acute or chronic infection including urinary tract infection, human immunodeficiency virus (HIV) or viral hepatitis
  • Prior use of niclosamide or allergies to niclosamide
  • Concomitant use of strong CYP3A4, CYP1A2, or CYP2C9 substrates
  • Pregnant and nursing women are excluded
  • Patients with complete bowel obstruction or who are at high risk for gastrointestinal (GI) perforation or severe hemorrhage and patients with inflammatory bowel disease

Locations & Contacts

North Carolina

Durham
Duke University Medical Center
Status: Active
Contact: Michael A. Morse
Phone: 919-668-1861
Email: michael.morse@dm.duke.edu

Trial Objectives and Outline

PRIMARY OBJECTIVE:

I. To evaluate the safety of niclosamide in patients with colon cancer undergoing primary resection of their tumor.

SECONDARY OBJECTIVES:

I. To characterize the pharmacokinetic (PK) profile of niclosamide.

II. To evaluate changes in the WNT pathway activation following oral administration of niclosamide.

OUTLINE: This is a dose-escalation study.

Patients receive niclosamide orally (PO) on days 1-7 and then undergo tumor resection surgery.

After completion of study treatment, patients are followed up at 30 days.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Duke University Medical Center

Principal Investigator
Michael A. Morse

Trial IDs

Primary ID Pro00066964
Secondary IDs NCI-2016-01245
Clinicaltrials.gov ID NCT02687009