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

NCT03233828 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: 4387
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma (Skin); Melanoma in Situ

Keywords

Intralesional Injection; Immunotherapy; Immune Response; Interleukin-2 (Aldesleukin); Tumor Infiltration; Metastasis Prevention

Outcome Measures

Primary Outcomes (2)

• Assessment of Number of Patients Needed to Obtain Significance

  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.

  1 year

• Assessment of Metastasis

  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.

  Assessments every 4 months for 2 years. Biannual assessments for years 3-5.

Secondary Outcomes (3)

• Assessment of RNA Genetic Profile

  RNA analysis of excised tissue up to 5 years.

• Assessment of Systemic Immune Response: Proteomic Analysis

  Proteomic analysis of serum samples up to 5 years

• Assessment of Systemic Immune Response: Metabolomic Analysis

  Metabolomic analysis of urine samples up to 5 years

Study Arms (2)

Intralesional IL-2 Injection

EXPERIMENTAL

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

Saline Injection

PLACEBO COMPARATOR

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

Interventions

Aldesleukin BIOLOGICAL

500,000 IU in 0.1mL

Intralesional IL-2 Injection

Saline OTHER

0.1 mL of sterile saline solution (0.9% m/v)

Saline Injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Carman Giacomantonio: lead
• Nova Scotia Health Authority: collaborator

Study Sites (1)

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H3G1, Canada

Location

Related Publications (6)

• Ranieri JM, Wagner JD, Wenck S, Johnson CS, Coleman JJ 3rd. The prognostic importance of sentinel lymph node biopsy in thin melanoma. Ann Surg Oncol. 2006 Jul;13(7):927-32. doi: 10.1245/ASO.2006.04.023. Epub 2006 May 22.

  PMID: 16788753 BACKGROUND

• Sandru A, Voinea S, Panaitescu E, Blidaru A. Survival rates of patients with metastatic malignant melanoma. J Med Life. 2014 Oct-Dec;7(4):572-6.

  PMID: 25713625 BACKGROUND

• Tsao H, Atkins MB, Sober AJ. Management of cutaneous melanoma. N Engl J Med. 2004 Sep 2;351(10):998-1012. doi: 10.1056/NEJMra041245. No abstract available.

  PMID: 15342808 BACKGROUND

• Hersey P, Gallagher S. Intralesional immunotherapy for melanoma. J Surg Oncol. 2014 Mar;109(4):320-6. doi: 10.1002/jso.23494. Epub 2013 Dec 3.

  PMID: 24301265 BACKGROUND

• Sloot S, Rashid OM, Sarnaik AA, Zager JS. Developments in Intralesional Therapy for Metastatic Melanoma. Cancer Control. 2016 Jan;23(1):12-20. doi: 10.1177/107327481602300104.

  PMID: 27009452 BACKGROUND

• Boyd KU, Wehrli BM, Temple CL. Intra-lesional interleukin-2 for the treatment of in-transit melanoma. J Surg Oncol. 2011 Dec;104(7):711-7. doi: 10.1002/jso.21968. Epub 2011 Jul 8.

  PMID: 21744347 BACKGROUND

Related Links

• New treatments for metastatic melanoma

MeSH Terms

Conditions

Melanoma

Interventions

aldesleukin; Sodium Chloride

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Principal Investigator
• Organization: Nova Scotia Health

carman.giacomantonio@nshealth.ca

9024736177

Study Officials

• Carman A Giacomantonio, MD, FRCSC

  Surgical Oncologist / General Surgeon / Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Surgical Oncologist / General Surgeon / Professor

Model Details: Patients will be given either intralesional IL-2 or intralesional saline as a control

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: July 31, 2017
• Study Start: October 30, 2019
• Primary Completion: November 27, 2019
• Study Completion: November 27, 2019
• Last Updated: July 24, 2024
• Results First Posted: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)