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Trial · Interventional

CompletedPhase 1/2Results postedRegistry data

Intratumoral Injections of LL37 for Melanoma

NCTNCT02225366 (opens ClinicalTrials.gov in a new tab)Other id2013-0422Other id5P50CA093459-08Other idNCI-2014-02012

Overview

Status
Completed
Phase
Phase 1/2
Enrollment
4 participants (actual)
Sponsor
M.D. Anderson Cancer Center · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
8 Jul 2015
Primary completion
24 Nov 2020
Completion
24 Nov 2020
First posted
26 Aug 2014 (estimated)
Last update posted
9 Dec 2021
Conditions
Melanoma

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2015201620172018201920202021
  1. Ph 1/2

    Intratumoral Injections of LL37 for Melanoma

    NCT02225366

    8 Jul 2015 to 24 Nov 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown 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.

Interventions

  • LL37Biological
  • PhotographsOther

Arms1

  • Experimental

    Intra-Tumoral Injection of LL37

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · once a week, up to 8 weeks duration

    Registry 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)
  1. Number of Participants With Antitumor Immune Response of Intra-Tumoral Injection of LL37

    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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· once a week, up to 8 weeks duration

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

GroupValue (Participants)
Cohort 12
Cohort 21
Secondary and other outcome results(1)
Secondary outcomeCount of participants· 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

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

GroupValue (Participants)
Cohort 12
Cohort 21

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Cohort 1This cohort received starting dose of 250 ug/tumor injection once a week0 / 20 / 22 / 2
Cohort 2This cohort received 500 ug/tumor injection once a week0 / 10 / 11 / 1

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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