Phase
Condition
Lung Cancer
Carcinoma
Treatment
Imiquimod 5% cream
5-fluorouracil
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Biopsy-confirmed SCC more than 1.0 cm and less than 2.0 cm in diameter in the lowerextremities, defined as the knees and below.
Subjects must have an expected survival of greater than or equal to12 months.
Subjects must not be on any other investigational device/drug treatment.
Subjects must to be willing to adhere to the instructions of the Investigator andhis research team and sign an Informed Consent Form prior to entry into the study.
Patient is ≥ 18 years of age on day of signing informed consent.
Patient must have a performance status of 0 or 1 on the Eastern Cooperative OncologyGroup (ECOG) Performance Scale.
Female patient of childbearing potential has a negative urine or serum pregnancytest within 7 days prior to receiving the first dose of study medication. If theurine test is positive or cannot be confirmed as negative, a serum pregnancy testwill be required. The serum pregnancy test must be negative for the patient to beeligible.
Female patients enrolled in the study, who are not free from menses for > 2 years,post hysterectomy/oophorectomy, or surgically sterilized, must be willing to useeither 2 adequate barrier methods or a barrier method plus a hormonal method ofcontraception to prevent pregnancy, or to abstain from heterosexual activitythroughout the study, starting with the first dose of study drug at visit 1 through 120 days after the last dose of study drug. Approved contraceptive methods includefor example: intra-uterine device, diaphragm with spermicide, cervical cap withspermicide, male condoms, or female condom with spermicide. Spermicides alone arenot an acceptable method of contraception. Male patients must agree to use anadequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study drug.
Exclusion
Exclusion Criteria:
Patients with any evidence of nodal (Nx) and/or metastatic disease including distantsubcutaneous and/or lymph node metastases.
Patients with primary non-cutaneous SCC - such as nasopharyngeal SCC.
Patient with history of receiving organ transplantation.
Patients with history of iatrogenic systemic immunosuppression.
Patients with a history of skin or other disorder(s),that in the opinion of theinvestigator, requires topical application of steroids and/or othercreams/ointments.
Patients with evidence of active infection - active and/or untreated hepatitis B/C,HIV, etc - requiring systemic therapy.
Patients with a known history of autoimmune disease.
Patients with the following cardiac co-morbidities including:
Baseline known prolongation of QT/QTc interval (QTc interval >500 msec).
Heart failure either on clinical examination (manifestations include ascites,cardiomegaly, dyspnea, edema, gallop rhythm, hepatomegaly, oliguria, pleuraleffusion, pulmonary edema, tachycardia) or based on known decreased leftventricular ejection fraction (LV EF) <50%.
Patients who have had chemotherapy, radioactive or biological cancer therapywithin four weeks prior to the first dose of study drug, or who has notrecovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 orbetter from the adverse effects (AEs) due to cancer therapeutics administeredmore than four weeks earlier. Subjects with ≤ grade 2 neuropathy are anexception to this criterion and may qualify for the study.
If patient received major surgery, they must have recovered adequately from thetoxicity and/or complications from the intervention prior to starting therapy.
Patients currently participating or who have participated in a study of aninvestigational agent or using an investigational device within 4 weeks of the firstdose of study drug.
Patients expected to require any other form of systemic or localized antineoplastictherapy while on study.
Patients with a known history of a hematologic malignancy, primary brain tumor orsarcoma, or of another primary solid tumor, unless the patient has undergonepotentially curative therapy with no evidence of that disease for five years.
° The time requirement also does not apply to patients who underwent successfuldefinitive resection of basal or squamous cell carcinoma of the skin, superficialbladder cancer, in situ cancers including cervical cancer, breast cancer, melanoma,or other in situ cancers.
Patients who have previously had a severe hypersensitivity reaction to 5-fluorouracil or imiquimod.
Serious illnesses, such as: cardiovascular disease (uncontrolled congestive heartfailure, hypertension, cardiac ischemia, myocardial infarction, and severe cardiacarrhythmia), bleeding disorders, autoimmune diseases, severe obstructive orrestrictive pulmonary diseases, active systemic infections, and inflammatory boweldisorders.
Patients with a history or current evidence of any condition, therapy, or laboratoryabnormality that might confound the results of the study, interfere with thepatient's participation for the full duration of the study, or are not in the bestinterest of the patient to participate, in the opinion of the treating Investigator.
Patients who are, at the time of signing informed consent, regularly using illicitdrugs or are recently (within the last year) abusing illicit substances (includingalcohol).
Patient is pregnant or breastfeeding, or expecting to conceive or father childrenwithin the projected duration of the study.
Study Design
Study Description
Connect with a study center
St. Margaret Hospital Dermatology
Pittsburgh, Pennsylvania 15238
United StatesActive - Recruiting
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