Clinical trial · Interventional
Intratumoral Injections of LL37 for Melanoma
Induction of Antitumor Response in Melanoma Patients Using the Antimicrobial Peptide LL37
NCT02225366CI-TRIAL-00055459completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical research study is to find the appropriate dose of LL37 that can be given to patients with melanoma. Researchers also want to learn if LL37 can stimulate the immune system to help control the disease.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LL37 | Biological | — | UNRESOLVED |
| Photographs | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intra-Tumoral Injection of LL37
- description
- LL37 administered intratumorally in cutaneous or subcutaneous tumors at least 1 cm in diameter. Patients will receive weekly intratumoral injections of LL37 for up to 8 weeks. The injections will be given every 7 days (+/- 48 hours). Starting dose 250 µg/tumor.
- interventionNames
- Biological: LL37
- Other: Photographs
Primary outcomes (1)
- measure
- Number of Participants With Optimal Biological Dose (OBD) of LL37 Based Upon Toxicity
- timeFrame
- once a week, up to 8 weeks duration
- description
- Dose Limiting Toxicity defined as: a. Any grade 3 or 4 non-hematologic toxicity regardless of duration, except: Grade 3 skin reactions at injection sites - Grade 3 fever b. Grade 4 thrombocytopenia c. Grade 4 neutropenia lasting \>2 weeks or associated with infection.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.