Intratumoral Injections of LL37 for Melanoma

Melanoma Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Melanoma

• NCT number: NCT02225366
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 8, 2015
• Completion date: November 24, 2020