A Phase 1/2 interventional study of LL37 and Photographs in Melanoma, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-09.
Sponsored by M.D. Anderson Cancer Center · Phase 1/2, Interventional, and Treatment
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:
On Day 1:
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:
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:
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:
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.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 4 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Biological: LL37 · Other: Photographs
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.
Number of Participants With Optimal Biological Dose (OBD) of LL37 Based Upon Toxicity
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.
Time frame: once a week, up to 8 weeks duration
Number of Participants With Antitumor Immune Response of Intra-Tumoral Injection of LL37
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.
Time frame: Radiologic evaluations in the form of CT scans of affected disease sites will be performed every 8 weeks (+/- 14 days) while on study, up to 1 year
| Milestone | Cohort 1 | Cohort 2 |
|---|---|---|
| Started | 2 | 1 |
| Completed | 1 | 1 |
| Not completed | 1 | 0 |
| Withdrew: Lack of efficacy | 1 | 0 |
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.
| Participants | Cohort 1 | Cohort 2 |
|---|---|---|
| Number of Participants With Optimal Biological Dose (OBD) of LL37 Based Upon Toxicity | 2 | 1 |
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.
| Participants | Cohort 1 | Cohort 2 |
|---|---|---|
| Number of Participants With Antitumor Immune Response of Intra-Tumoral Injection of LL37 | 2 | 1 |
Collected over adverse events were collected every week at the time of the injections for up to 8 weeks, All-Cause Mortality was assessed up to 14 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Cohort 2 | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Event | Cohort 1 | Cohort 2 |
|---|---|---|
| AnemiaBlood and lymphatic system disorders | 1/2 | 1/1 |
| Lymphocyte Count DecreaseBlood and lymphatic system disorders | 0/2 | 1/1 |
| White blood cell decreaseBlood and lymphatic system disorders | 0/2 | 1/1 |
| Blood bilirubin increaseBlood and lymphatic system disorders | 0/2 | 1/1 |
| Squamous Cell CarcinomaSkin and subcutaneous tissue disorders | 1/2 | 0/1 |
| Actinic KeratosisSkin and subcutaneous tissue disorders | 1/2 | 0/1 |
| Skin hypopigmentationSkin and subcutaneous tissue disorders | 1/2 | 0/1 |
| HypothyroidismEndocrine disorders | 1/2 | 0/1 |
| Age, Categorical(Participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 2 | 1 | 3 |
| Sex: Female, Male(Participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Female | 2 | 0 | 2 |
| Male | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 2 | 1 | 3 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| United States | 2 | 1 | 3 |
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