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Pre-Treatment of Highly Suspicious Pigmented Skin Lesions With Interleukin-2 (IL-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03233828
Recruitment Status : Recruiting
First Posted : July 31, 2017
Last Update Posted : April 16, 2020
Sponsor:
Collaborator:
Nova Scotia Health Authority
Information provided by (Responsible Party):
Carman Giacomantonio, Nova Scotia Health Authority

Brief Summary:

This study is meant to assess the use of intralesional IL-2 to modulate the immunological response to suspected melanoma, or melanoma in situ, in an effort to increase lymphocyte infiltration and decrease disease metastasis.

Patients that are clinically diagnosed with suspected Melanoma or Melanoma in situ will be assigned to either a treatment or control arm. The treatment group will be subjected to two intralesional IL-2 injections, whereas the control group will be subjected to two intralesional injections of saline.

The proteomic and metabolomic profiles of both groups will be analyzed using urine and blood samples in an effort to assess the systemic immunological response, if any, to the treatment. Also, upon disease confirmation and staging by a qualified pathologist, lesions will be assessed for lymphocyte infiltration using immunohistochemical methods.

This study will determine whether pre-treatment of IL-2 on lesions (clinically diagnosed as melanoma or melanoma in situ) is effective in generating an adaptive immune response, and whether that immune response may play a role in preventing disease metastasis.


Condition or disease Intervention/treatment Phase
Melanoma (Skin) Melanoma in Situ Biological: Aldesleukin Other: Saline Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be given either intralesional IL-2 or intralesional saline as a control
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Pre-Treatment of Highly Suspicious Pigmented Skin Lesions With Interleukin-2
Actual Study Start Date : December 19, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2023


Arm Intervention/treatment
Experimental: Intralesional IL-2 Injection
Two subcutaneous intralesional injections of Aldesleukin, prepared by the pharmacy such that the contents will be masked, will be administered by the care provider in a clinic seven days apart.
Biological: Aldesleukin
500,000 IU in 0.1mL

Placebo Comparator: Saline Injection
Two subcutaneous intralesional injections of Saline, prepared by the pharmacy such that the contents will be masked, will be administered by the care provider in a clinic seven days apart.
Other: Saline
0.1 mL of sterile saline solution (0.9% m/v)




Primary Outcome Measures :
  1. Assessment of Number of Patients Needed to Obtain Significance [ Time Frame: 1 year ]
    Data will be analyzed in order to achieve a statistically significant differentiation between treatment and control outcomes in study measures including tumor infiltrating lymphocytes (TILs) and circulating immunomodulators.

  2. Assessment of Metastasis [ Time Frame: 5 years ]
    All patients will receive assessments every 4 months for 2 years and then biannual assessments for years 3-5 after the initial intervention to assess disease metastasis in treatment and control groups. Both number of new metastases (integer value) and thickness (mm) will be measured as a part of this assessment.


Secondary Outcome Measures :
  1. Assessment of RNA genetic profile [ Time Frame: 5 years ]
    RNA analysis of excised tissue will be compared to unaffected patient tissue obtained from the clear margins of the excisional biopsy to assess genetic changes resulting from the melanoma and treatment/placebo injections. RNA analysis will occur at Dr. Giacomantonio's laboratory (Sir Charles Tupper Medical Building, 11F11) at Dalhousie University.

  2. Assessment of Systemic Immune Response: Proteomic Analysis [ Time Frame: 5 years ]
    Proteomic analysis will be conducted on blood samples to assess systemic immune response to both treatment and control groups. Serum collected from patient blood samples will be used for proteomic analysis to assess protein expression, including circulating immunomodulators (cytokines and chemokines) before, and after, treatment. Proteomic analysis will occur at Dalhousie's Proteomics and Mass Spectrometric Core Facility located in the Life Sciences Research Institute. This study may serve to help develop diagnostic protocols and methods of assessing response to treatments.

  3. Assessment of Systemic Immune Response: Metabolomic Analysis [ Time Frame: 5 years ]
    Metabolomic analysis will be conducted on urine samples to assess systemic immune response to both treatment and control groups. All tumor and tissue produce by products in waste that are excreted by the kidneys. Urine samples can be evaluated using techniques, such as Mass Spectrometric, to determine if biological compounds can be identified in association with the presence of a malignant process that would not be produced by normal tissue. Metabolome analysis will occur at Dalhousie's Proteomics and Mass Spectrometric Core Facility located in the Life Sciences Research Institute. This study may serve to help develop diagnostic protocols and methods of assessing response to treatments.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The participant population will include patients characterized by: nodular/polypoid features, bleeding/ulcerated lesions, excluding face and vulvo-genital lesions.

Exclusion Criteria:

  • Participants who are not: currently immunocompromized, on immuno-therapy for other diagnosis, have known inflammatory or autoimmune diseases or are otherwise incapacitated.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233828


Contacts
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Contact: Cheryl A Dean, M.SC 9028301890 cheryldean597@gmail.com
Contact: Gordon A Simms, PhD 9024943447 gasimms@dal.ca

Locations
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Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre Recruiting
Halifax, Nova Scotia, Canada, B3H3G1
Contact: Cheryl A Dean    9028301890    cheryldean597@gmail.com   
Contact: Gordon A Simms, PhD    9024943447    gasimms@dal.ca   
Sponsors and Collaborators
Carman Giacomantonio
Nova Scotia Health Authority
Investigators
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Principal Investigator: Carman A Giacomantonio, MD, FRCSC Surgical Oncologist / General Surgeon / Professor
Additional Information:
Publications:
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Responsible Party: Carman Giacomantonio, Surgical Oncologist / General Surgeon / Professor, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT03233828    
Other Study ID Numbers: 4387
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Carman Giacomantonio, Nova Scotia Health Authority:
Intralesional Injection
Immunotherapy
Immune Response
Interleukin-2 (Aldesleukin)
Tumor Infiltration
Metastasis Prevention
Additional relevant MeSH terms:
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Melanoma
Pigmentation Disorders
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Skin Diseases
Pathologic Processes
Aldesleukin
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents