Overview
Ifetroban in Treating Patients With Malignant Solid Tumors at High Risk of Metastatic Recurrence
Status:
Recruiting
Recruiting
Trial end date:
2025-01-01
2025-01-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This pilot trial studies the side effects of ifetroban in treating patients with malignant solid tumors that are at high risk of coming back after treatment and spreading throughout the body. Platelets are a type of blood cells that help with clotting. Cancer cells stick to platelets and ride on them to get to different parts of the body. Drugs, such as ifetroban, may help these platelets become less "sticky," and reduce the chance of cancer cells spreading to other places in the body.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Vanderbilt-Ingram Cancer CenterCollaborator:
Cumberland PharmaceuticalsTreatments:
Ifetroban
Criteria
Inclusion Criteria:- Signed and dated written informed consent.
- Subjects ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- Current diagnosis of any stage I to III malignant solid tumor at high risk of
metastatic recurrence (deemed by treating physician as patients with ≥ 50% chance of
cancer metastatic recurrence within 5 years of diagnosis)
- Patients must have completed all standard locoregional and systemic therapy for their
cancer within 120 days of study enrollment.
- Administration of an investigational agent prior to enrollment needs to be completed
at least 30 days prior to enrollment
- Patients must have recovered (≤ grade 1 toxicities or grade 2 toxicities well managed
with optimal medical care) from effects of local (surgery, radiation) or systemic
treatments.
- Platelet count ≥ 100,000 per mL of blood
- Hemoglobin ≥ 9/g/dL (may have been transfused)
- Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 50 mL/min as
calculated using the Cockcroft-Gault (CG) equation
- Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 2.5 ×
ULN
- INR below upper limit of normal (ULN)
- Female patients of childbearing potential and non-sterile males must agree to use at
least two methods of acceptable contraception from 15 days prior to first trial
treatment administration until at least 5 months after study participant's final dose
of study drug
Note: Females of childbearing potential are defined as those who are not surgically sterile
or post-menopausal (i.e. patient has not had a bilateral tubal ligation, a bilateral
oophorectomy, or a complete hysterectomy; or has not been amenorrheic for 12 months without
an alternative medical cause). Post-menopausal status in females under 55 years of age
should be confirmed with a serum follicle-stimulating hormone (FSH) level within laboratory
reference range for postmenopausal women. Non-sterile males are those who have not had a
vasectomy with documentation of the absence of sperm in the ejaculate.
- Patients unable to read/write in English are eligible to participate in the overall
study but will not participate in the Patient-Reported Outcome questionnaires
throughout the trial.
- Re-enrollment of a subject that has discontinued the study as a pre-treatment screen
failure (i.e. a consented patient who did not receive study drugs) is permitted. If
reenrolled, the subject must be re-consented. Only the screening procedures performed
outside of protocol-specified timing must be repeated.
Exclusion Criteria:
- Evidence of biopsy-proven distant metastatic disease after completion of standard
treatment
- Current use of anti-platelet drugs (ASA, NSAIDs, clopidogrel, argatroban, etc.) or
anticoagulants (warfarin, heparin products, etc.)
- Active malignancy within 5 years prior to current diagnosis except for in situ disease
or cancer with very high curability rate (i.e. testicular cancer, etc.)
- Uncontrolled co-morbid serious systemic illnesses that in the opinion of the
investigator could compromise therapeutic safety.
- No concurrent anticancer therapy. Required washout from prior therapy:
- Chemotherapy: 21 days
- Major surgery: 14 days (provided wound healing is adequate)
- Radiation: 7 days
- Investigational/Biologic Therapy: 30 days
- Current symptomatic congestive heart failure (New York Heart Association > class II),
unstable cardiac arrhythmia requiring therapy (e.g. medication or pacemaker), unstable
angina (e.g. new, worsening or persistent chest discomfort), or uncontrolled
hypertension (systolic > 160 mmHg or diastolic > 100mmHg). Or any of the following
occurring within 6 months (180 days) prior to first dose of study drugs: Myocardial
infarction, coronary/peripheral artery bypass graft, cerebrovascular accident or
transient ischemic attack. (Use of antihypertensive medication to control blood
pressure is allowed.)
- Ongoing peptic ulcer disease requiring treatment
- History of gastrointestinal bleed
- Severe gastro-esophageal reflux disease requiring treatment
- History of bleeding diathesis
- Pregnant or breastfeeding females.
- Prisoners or subjects who are involuntarily incarcerated.
- Known psychiatric condition, social circumstance, or other medical condition
reasonably judged by the patient's study physician to unacceptably increase the risk
of study participation; or to prohibit the understanding or rendering of informed
consent or anticipated compliance with scheduled visits, treatment schedule,
laboratory tests and other study requirements.