The Response to Intralesional IL-2 and/or BCG Treatment for Cutaneous Metastatic Melanoma

Carman Giacomantonio

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Cutaneous Metastatic Melanoma

Treatments: Biological: Combination therapy Interleukin-2 and Bacillus Calmette Guerin; Biological: Interleukin-2

Study type: Interventional

Funder types: Other

Identifiers

NCT03928275

14549

Details and patient eligibility

About

The investigators aim to include 100 local participants over the next 5 years in a two-stage sequential randomized interventional study of intralesional Interleukin-2 (IL-2) and Bacillus Calmette Guerin (BCG) to assess the utility of treating cutaneous metastatic melanoma (CMM).

Full description

In the first stage of the study, all consenting CMM patients will be randomized and will receive 4 treatments of either intralesional IL-2 or intralesional IL-2 and BCG. We hypothesize that patients with MM (stage 3C or 4a with a minimum of 4 lesions) that receive combination therapy (IL-2/BCG) in the first stage of treatment will have a higher complete response (iCR) rate compared to IL-2 therapy alone.

Response to stage-one treatment will be monitored and patient response to treatment will be determined and reported according to Immune Response Evaluation Criteria in Solid Tumours (iRECIST) guidelines. Based on response to stage-one treatment, patients will be placed into a response group before entering stage two. For stage two of the trial, patients will be randomized again, and placed into a treatment group; Il-2, IL-2 and BCG, BCG, or Discontinue Treatment. Response to treatment will be monitored and patient response to treatment will be determined and reported according to iRECIST guidelines.

All patients will have lesions biopsied following standard surgical practice techniques and will provide urine and blood for analysis. Tissue samples will be assessed for immune system activity and transcriptome analysis, and urine and blood will be assessed for immune cell populations and markers. All patients will be followed for 5 years post treatment, and patient disease and survival status will be recorded according to iRECIST.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with cutaneous metastatic melanoma.
• Has 4 or more melanoma lesions.
• Between18 and 80 years of age.

Exclusion criteria

• Immunocompromized.
• Receiving immuno-therapy for other diagnosis.
• Inflammatory disease.
• Autoimmune disease.
• Pregnant
• HIV
• Test positive for TB

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Intralesional IL-2 Treatment

Experimental group

Description:

CMM patients will received 4 treatments of intralesional Interleukin-2 two weeks apart over an eight week period.

Treatment:

Biological: Interleukin-2

Combination therapy: Intralesional IL-2 and BCG Treatment

Experimental group

Description:

CMM patients will receive 4 treatments of combination therapy intralesional Interleukin-2 and Bacillus Calmette Guerin two weeks apart over an eight week period.

Treatment:

Biological: Combination therapy Interleukin-2 and Bacillus Calmette Guerin