Symptoms and General Pathology

All Conditions

Heart and Blood Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Nervous System Diseases

Musculoskeletal Diseases

Inflammation

Diabetic Foot

Necrosis

Ulcer

Foot Ulcer

Diabetic Angiopathies

Vascular Diseases

Leg Ulcer

Skin Ulcer

Skin Diseases

Diabetes Mellitus

Diabetes Complications

Endocrine System Diseases

Diabetic Neuropathies

Foot Diseases

0.5 mg/mL LL-37 cream, administered twice a week for 4 weeks

Placebo cream, administered twice a week for 4 weeks

LL37

Standard Wound Care

Eliza Miranda, MD

Luddwi A Rizky, MD

Diabetic foot ulcer (DFU) is a common complication of diabetes with global prevalence of 6.3%. Treatment of diabetic foot ulcer (DFU) is challenging with disappointing outcome. Wound debridement, infection control, pressure relief and revascularization are main pillars of DFU management. Various substances and modalities are being investigated for their potential effects in treating DFU, one of which is LL-37.

In this randomized, controlled trial, 40 patients with uncomplicated DFU will be enrolled. Patients are randomly assigned to undergo twice a week treatment with 0.5 mg/mL LL-37 cream (treatment group) or placebo cream (control group) for 4 weeks in addition to standard wound care. The primary outcomes are the healing rate measured by wound area and granulation index and changes in patterns of aerobic bacteria colonization during the 4-week study duration and changes in concentrations of IL-α and TNF-α from fluid collected from DFU on the end of the second and third week of study compared to baseline.

Efficacy of LL-37 Cream on Bacteria Colonization, Inflammation Response and Healing Rate of Diabetic Foot Ulcers

The Efficacy of LL-37 Cream on Aerobic Bacteria Colonization Pattern, Inflammation Response: Interleukin 1α (IL-1α) and Tumor Necrosis Factor α (TNF-α), and Healing Rate of Diabetic Foot Ulcers

Measured by difference of granulation index by ImageJ

Measured by the species of bacteria grown on culture and the quantities of their colonies in CFU/swab

Measured by the concentrations of IL-α and TNF-α by ELISA

Fakultas Kedokteran Universitas Indonesia

Staff of Tropical Infection Division, Department of Dermatology and Venereology

Neoplasms

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Neuroendocrine Tumor

Neuroepithelioma

Anti-Infective Agents

All Drugs and Chemicals

Anti-Bacterial Agents

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.

Starting dose 250 µg/tumor. The injections will be given every 7 days for up to 8 weeks.

Tumors measured and photographed one week before receiving LL37, and again at 4 weeks after LL37. Then photographs of the LL37 injected sites taken at 8 weeks.

Photographs

Rodabe N. Amaria, MD

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.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of LL37 based on when you join this study. Up to 4 dose levels of LL37 will be tested. Up to 2 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of LL37 is found.

Study Drug Administration:

One (1) time a week for 8 weeks, LL37 will be injected into 2-4 tumors. The injections will be done in the clinic.

Study Visits:

Within 1 week before your first study drug injection:

* You will have a physical exam.
* You will have a punch biopsy of a tumor. To collect a punch biopsy, the area of skin is numbed with anesthetic and a small cut is made to remove all or part of the affected tissue.
* Blood (about 1 teaspoon) will be drawn for routine tests.
* The tumors will be measured and photographed. Your private areas will be covered (as much as possible), and a picture of your face will not be taken unless there are tumors on your face.

On Day 1:

* You will have a physical exam.
* Blood (about 1 teaspoon) will be drawn for routine tests.

On Day 2, you will have a punch biopsy of one of the injected tumors.

At Weeks 1, 2, 3, 4, 5, 6, 7, and 8:

* You will have a physical exam.
* Blood (about 1 teaspoon) will be drawn for routine tests.
* At Weeks 1, 3, and 5 and 7, blood (about 4 tablespoons) will be drawn to study your immune response to LL37.

At Week 4, you will have a punch biopsy of one of the injected tumors and one of the tumors that you did not have an injection in. Photos of the tumors will be taken to show if the disease has responded to the study drug.

At Week 8:

* Photos of the LL37 injected sites will be taken to show if the disease has responded to the study drug.
* You will have CT scans to check the status of the disease.

Length of Treatment:

You will receive up to 8 weeks of study treatment. You will be taken off study if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over after the follow-up visits.

Off-Study Visit:

If you have to stop the study treatment earlier than planned because the disease got worse or you had intolerable side effects:

* You will have a physical exam.
* The tumors will be photographed and measured.
* Blood (about 4 teaspoons) will be drawn for routine tests and to study your immune response to LL37.
* You will have CT scans to check the status of the disease.
* You will have a punch biopsy of one of the injected tumors.

These off-study procedures will be completed within 14 days after your last dose of study treatment. You will be contacted by phone or clinic visit at 30 days (+/- 7 days) after your last dose to follow up on any drug-related toxicities which were present at the end of study.

Follow-Up:

Within 2 weeks after your last study drug dose and every 8-12 weeks after that, you will have scans to check the status of the disease. Your doctor will decide what type of scans you will have.

After your last study drug dose, at your routine clinic visits every 3 months for 1 year, the study staff will ask you about the status of disease, if possible. If you do not plan to continue to receive medical care at MD Anderson, the study staff will contact you by phone, email, or letter to ask about the status of disease. The calls should last about 5 minutes.

This is an investigational study. LL37 is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work.

Up to 36 participants will be treated in this study. All will take part at MD Anderson.

Intratumoral Injections of LL37 for Melanoma

Induction of Antitumor Response in Melanoma Patients Using the Antimicrobial Peptide LL37

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.

Response defined as experiencing either an immune-related complete or partial response (irCR or irPR), and the association between response and disease characteristics and T-cell responses will be assessed using logistic regression.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

This cohort received starting dose of 250 ug/tumor injection once a week

Cohort 1

This cohort received 500 ug/tumor injection once a week

Cohort 2

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Rodabe Amaria,MD, Associate Professor, Melanoma Medical Oncology

Number of Participants With Optimal Biological Dose (OBD) of LL37 Based Upon Toxicity

Number of Participants With Antitumor Immune Response of Intra-Tumoral Injection of LL37

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy of LL-37 Cream on Bacteria Colonization, Inflammation Response and Healing Rate of Diabetic Foot Ulcers	NCT04098562	Diabetic Foot U...	LL37 Standard Wound ...	18 Years - 60 Years	Fakultas Kedokteran Universitas Indonesia
Intratumoral Injections of LL37 for Melanoma	NCT02225366	Melanoma	LL37 Photographs	18 Years -	M.D. Anderson Cancer Center
Efficacy of LL-37 Cream on Bacteria Colonization, Inflammation Response and Healing Rate of Diabetic Foot Ulcers	NCT04098562	Diabetic Foot U...	LL37 Standard Wound ...	18 Years - 60 Years	Fakultas Kedokteran Universitas Indonesia

Spots Global Cancer Trial Database for ll37

Every month we try and update this database with for ll37 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ll37

Every month we try and update this database with for ll37 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ll37 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.