Chemoprevention of Gastric Carcinogenesis

• Status: Recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborators: Cancer Prevention Pharmaceuticals, Inc.; National Cancer Institute (NCI)
• Treatments: Eflornithine

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.