IL-2 SELECT Tissue Collection Protocol in Patients With Advanced Melanoma

Study Overview
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Brief Summary
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The purpose of this study is to determine which participants with melanoma have a better response to IL-2 and to identify markers that may predict response to IL-2 by collecting participant information (for example; cancer diagnosis and history, prior treatments for cancer, etc.) blood and tumor samples prior to treatment and tumor measurements after treatment.

Detailed Description
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Original tumor slides will be collected to identify tumor markers that may predict responses to treatment. Blood samples will be obtained prior to treatment with IL-2.

Official Title
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The High-Dose Aldesleukin (IL-2) SELECT Trial: A Prospective Tissue Collection Protocol to Investigate Predictive Models of Response to High-Dose IL-2 Treatments in Patients With Advance Melanoma

Conditions
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Malignant Melanoma

Intervention / Treatment
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* Drug: IL-2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Malignant melanoma that is metastatic or unresectable Eligible to receive high-dose IL-2 Tissue block available with adequate tumor to perform RNA extraction and DASL analysis Exclusion Criteria: Prior immunotherapy for unresectable or metastatic disease Untreated brain metastases, leptomeningeal disease, or seizure disorder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IL-2 subjects<br>Subjects receiving IL-2 for advanced melanoma | Drug: IL-2<br>* Observation only<br>* Other names: aldesleukin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if DASL subclassification can identify a group of patients with advanced melanoma who are significantly more likely to respond to high dose IL-2 based on therapy than the historical 16% response rate in an unselected patient population |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To validate the usefulness of serum fibronectin and VEGF levels as negative predictors of response |  | 2 years | 
| To explore the predictive value of several genetic polymorphisms associated with immune function |  | 2 years | 
| To explore the predictive value of BRAF^V600E mutational status as a predictor of response and benefit to high dose IL-2 |  | 2 years | 
| To explore the relationship of serum fibronectin and VEGF levels with the molecular signature of immune responsiveness in patients with advanced melanoma receiving high-dose IL-2 in order to identify specific cohorts with dramatic differences in response |  | 2 years | 
| To identify new proteins or patterns of gene expression that might be associated with high-dose IL-2 responsiveness in order to further narrow the application of IL-2 therapy to those who will benefit the most |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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melanoma, IL-2, Aldesleukin