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

NCT03233828 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2024-07-24

Study results available
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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

Interventions

BIOLOGICAL

Aldesleukin

500,000 IU in 0.1mL

OTHER

Saline

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

Sponsors & Collaborators

  • Nova Scotia Health Authority

    collaborator OTHER

  • Carman Giacomantonio

    lead OTHER

Principal Investigators

  • Carman A Giacomantonio, MD, FRCSC · Surgical Oncologist / General Surgeon / Professor

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-30
Primary Completion
2019-11-27
Completion
2019-11-27
FDA Drug
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03233828 on ClinicalTrials.gov