Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-24 @ 4:18 PM
NCT ID:
NCT02225366
Eligibility Criteria:
Inclusion Criteria:
1. Patients with histologically documented metastatic melanoma with at least 3 cutaneous lesions measuring over 5mm diameter. At least two lesions must be at least 10mm in diameter to serve as the injected disease. At least one other lesion measuring at least 5mm in diameter may serve as the non-injected lesion that will be measurable disease. Patients will have stage IIIB or IIIC (in-transit lesions with or without nodal metastases) or stage IV M1A disease with cutaneous or nodal lesions assessable for administration of LL37. Patients are only eligible if their melanoma deposits are not amenable to complete surgical excision. Skin lesions that are 5mm or greater are deemed measurable however lesions that are at least 10mm in diameter will be preferentially utilized for LL37 injection.
2. Age greater than or equal to 18 years
3. Clinical performance status of ECOG 0-2 within 30 days of signing informed consent.
4. Total bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl.
5. Platelet count greater than or equal to 100,000/mm\^3
6. WBC \>/=3000/mm\^3
7. Serum ALT and AST less than three times the upper limit of normal
8. Serum creatinine \</= 2.0 mg/dl
9. Seronegative for HIV antibody
10. Patients with a negative pregnancy test (urine or serum) must be documented within 28 days of starting treatment for women of childbearing potential (WOCBP).
11. Unless surgically sterile by bilateral tubal ligation or vasectomy of partner(s), the patient agrees to continue to use a barrier method of contraception throughout the study such as: condom, diaphragm, hormonal, IUD, or sponge plus spermicide. Abstinence is an acceptable form of birth control.
Exclusion Criteria:
1. Active autoimmune disease requiring disease modifying therapy.
2. Concurrent systemic steroid therapy
3. Any form of active primary or secondary immunodeficiency
4. Prior malignancy except the following: adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, thyroid cancer (except anaplastic) or any cancer from which the patient has been disease-free for 2 years.
5. History of immunization with LL37
6. Active systemic infections requiring intravenous antibiotics
7. Prior systemic therapy, radiation therapy, or surgery within 28 days of starting study treatment
8. Patients who are pregnant or nursing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02225366
Study Brief:
Protocol Section:
NCT02225366