Intratumoral Injections of LL37 for Melanoma

NCT02225366 | Completed Phase 1 Results DMC FDA Drug

• 3 other identifiers: 2013-04225P50CA093459-08NCI-2014-02012
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Melanoma

Keywords

Melanoma; Metastatic; Antimicrobial peptide; LL37; Photographs

Outcome Measures

Primary Outcomes (1)

• 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.

  once a week, up to 8 weeks duration

Secondary Outcomes (1)

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

  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

Study Arms (1)

Intra-Tumoral Injection of LL37

EXPERIMENTAL

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

Interventions

LL37 BIOLOGICAL

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

Intra-Tumoral Injection of LL37

Photographs OTHER

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.

Intra-Tumoral Injection of LL37

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age greater than or equal to 18 years
• Clinical performance status of ECOG 0-2 within 30 days of signing informed consent.
• 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.
• Platelet count greater than or equal to 100,000/mm\^3
• WBC \>/=3000/mm\^3
• Serum ALT and AST less than three times the upper limit of normal
• Serum creatinine \</= 2.0 mg/dl
• Seronegative for HIV antibody
• Patients with a negative pregnancy test (urine or serum) must be documented within 28 days of starting treatment for women of childbearing potential (WOCBP).
• 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.

You may not qualify if:

• Active autoimmune disease requiring disease modifying therapy.
• Concurrent systemic steroid therapy
• Any form of active primary or secondary immunodeficiency
• 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.
• History of immunization with LL37
• Active systemic infections requiring intravenous antibiotics
• Prior systemic therapy, radiation therapy, or surgery within 28 days of starting study treatment
• Patients who are pregnant or nursing

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis

Interventions

Moire Topography

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Photogrammetry; Photography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Interferometry; Investigative Techniques

Results Point of Contact

• Title: Dr. Rodabe Amaria,MD, Associate Professor, Melanoma Medical Oncology
• Organization: UT MD Anderson Cancer Center

rnamaria@mdanderson.org

(713) 792-2921

Study Officials

• Rodabe N. Amaria, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2014
• First Posted: August 26, 2014
• Study Start: July 8, 2015
• Primary Completion: November 24, 2020
• Study Completion: November 24, 2020
• Last Updated: December 9, 2021
• Results First Posted: December 9, 2021

Record last verified: 2021-12

Locations

US (1)