Clinical trial · Interventional
Pre-Treatment of Highly Suspicious Pigmented Skin Lesions With Interleukin-2
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low enrollment numbers.
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma in Situ | Melanoma In Situ | ONTOLOGY_EXACT | 0.98 |
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aldesleukin | Biological | Aldesleukin | ALIAS |
| Saline | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intralesional IL-2 Injection
- description
- 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.
- interventionNames
- Biological: Aldesleukin
- type
- PLACEBO_COMPARATOR
- label
- Saline Injection
- description
- 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.
- interventionNames
- Other: Saline
Primary outcomes (2)
- measure
- Assessment of Number of Patients Needed to Obtain Significance
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (6)
- BACKGROUNDRanieri 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
- BACKGROUNDSandru 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
- BACKGROUNDTsao 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
- BACKGROUNDHersey 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
- BACKGROUNDSloot 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
- BACKGROUNDBoyd 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