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Trial record 1 of 1 for:    difluoromethylornithine | Honduras
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Chemoprevention of Gastric Carcinogenesis

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ClinicalTrials.gov Identifier: NCT02794428
Recruitment Status : Recruiting
First Posted : June 9, 2016
Last Update Posted : September 10, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Cancer Prevention Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Douglas Morgan, Vanderbilt-Ingram Cancer Center

Brief Summary:
A clinical study of the efficacy of oral alpha-difluoromethylornithine (eflornithine or DFMO) in male and female subjects ages 30-60 with gastric premalignant lesions in two high risk regions of Latin America.

Condition or disease Intervention/treatment Phase
Gastric Cancer Gastric Intestinal Metaplasia Drug: Eflornithine Other: Eflornithine placebo Phase 2

Detailed Description:
The primary intervention is the randomized, double-blind assignment of patients to once daily eflornithine (500 mg) versus placebo for an 18 month treatment period. Gastric precancerous lesions are defined as chronic atrophic gastritis (CAG) and intestinal metaplasia (IM). Patients will be clinically assessed with endoscopy and gastric biopsy at four time points: 0, 6, 18, and 24 months. The assessments at 0 and 24 months are considered part of usual clinical care in subjects with precancerous lesions in high risk regions. Overall, the efficacy of eflornithine is assessed by its effect on: 1) DNA damage, and 2) histology scoring.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Targeted Chemoprevention of Gastric Carcinogenesis in High Risk Populations
Actual Study Start Date : September 19, 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Eflornithine Drug: Eflornithine
Eflornithine*, 2 tablets, Oral, Daily for 18 months

Placebo Comparator: Eflornithine Placebo Other: Eflornithine placebo
Eflornithine placebo, 2 tablets, Oral, Daily for 18 months




Primary Outcome Measures :
  1. The difference in cell DNA damage between patients treated with DFMO and patients treated with placebo at 6 months. [ Time Frame: at 6 months ]
    The cell DNA damage is measured using the percent positive cells assessed by quantitative 8-OHdG immunohistochemistry (IHC). The mean difference between the two groups at 6 months will be calculated, accounting for their baseline measurements.


Secondary Outcome Measures :
  1. The difference in cell DNA damage between patients treated with DFMO and patients treated with placebo for 18 months, and then followed for an additional 6 months. [ Time Frame: at 18 and 24 months ]
    The cell DNA damage is measured using the percent positive cells assessed by quantitative 8-OHdG immunohistochemistry (IHC). The mean difference between the two groups at 18 and 24 months will be calculated, accounting for their baseline measurements.The additional measure of DNA damage (gamma H2AX by IHC and by flow cytometry will also be assessed at 0, 6, 18, and 24 months).

  2. The differences in the gastritis histopathology score between patients treated with DFMO and patients treated with placebo for a total of 18 months, and followed for an additional 6 months. [ Time Frame: at 6, 18 and 24 months ]
    The gastritis histopathology score is measured with a quantitative scale 0.0-6.0, for atrophy, intestinal metaplasia, and dysplasia. The mean differences between the two groups at 6, 18, and 24 months will be calculated using mixed models, accounting for their baseline measurements.

  3. Number of patients with quantitative toxicities. [ Time Frame: at 6, 18, and 24 months ]
    Toxicities will be assessed per CTCAE criteria, and each toxicity will be assigned an adverse event (AE) term according to CTCAE definitions (each AE term = unique representation of a specific event used for medical documentation and scientific analyses), and graded as defined by CTCAE (grade 1 = mild; grade 2 = moderate; grade 3 = severe or significant but not immediately life-threatening; grade 4 = life-threatening; grade 5 = death).



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Ages Eligible for Study:   30 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have a history of a premalignant lesion of the stomach, atrophic gastritis or intestinal metaplasia
  • Patients must have a pure tone audiometry evaluation to document air conduction within 60 days prior to randomization.
  • Patients must have adequate blood counts as evidenced by the following results (obtained within 60 days):

    • Blood counts: WBC ≥4.0 /mcL, platelets ≥100,000 /mcL and hemoglobin ≥11.0 g/dL
    • Kidney function: Creatinine <1.6 x IULN (institutional upper limit of normal)
    • Liver function tests: Bilirubin ≤2.0 mg/dL and AST (SGOT) or ALT (SGPT) ≤2 x IULN

Exclusion Criteria:

  • Subjects with dysplasia (indeterminate, low grade, high grade) are not eligible for participation
  • Patients must not have a significant medical or psychiatric condition that would preclude study completion.
  • Patients with hearing loss ≥30 dB in any of the tested frequencies (250 Hz, 500 Hz, 1,000 Hz, 2,000 Hz, 4,000 Hz, 8,000 Hz) are not eligible.
  • Patients must not have known hypersensitivity to eflornithine or the excipients.
  • Patients must not be receiving corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or anticoagulants on a regular or intermittent basis.
  • Patients must not have a significant cardiovascular disease history, including uncontrolled blood pressure (sBP > 150 mmHg), myocardial infarction, cerebrovascular accident, or heart failure (New York Heart Association Class III, or IV).
  • Patients must not have a history of gastric or esophageal cancer, gastric resection or surgery, peptic ulcer disease (within 6 months), H. pylori treatment (within 6 months), or inflammatory bowel disease.
  • No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for >5 years.
  • Patients must not be receiving corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or anticoagulants on a regular or intermittent basis.
  • Patients must not be pregnant or nursing (due to eflornithine pregnancy class C). Women and men of reproductive potential must have agreed to use an effective contraceptive method.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794428


Contacts
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Contact: VICC Clinical Trials Office 800-811-8480 cip@vanderbilt.edu

Locations
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Honduras
Ministry of Health, Hospital de Occidente Recruiting
Copán, Honduras
Principal Investigator: Ricardo Dominguez, MD         
Puerto Rico
University of Puerto Rico, Comprehensive Cancer Center Recruiting
San Juan, Puerto Rico
Contact: MD, PhD         
Principal Investigator: Marcia Cruz Correa, MD, PhD         
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Cancer Prevention Pharmaceuticals, Inc.
Investigators
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Study Chair: Doug Morgan, MD Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer enter
Principal Investigator: Keith Wilson, MD Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer enter
Additional Information:
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Responsible Party: Douglas Morgan, Director, Latin America sites, Vanderbilt Institute for Global Health, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT02794428    
Other Study ID Numbers: VICC GI 1527
6R01CA190612-03 ( U.S. NIH Grant/Contract )
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Douglas Morgan, Vanderbilt-Ingram Cancer Center:
Gastric adenocarcinoma
Gastric intestinal metaplasia
Atrophic gastritis
Gastric premalignant lesion
Additional relevant MeSH terms:
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Eflornithine
Carcinogenesis
Metaplasia
Neoplasms
Pathologic Processes
Neoplastic Processes
Antineoplastic Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Ornithine Decarboxylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action