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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01288963

Enrollment

153

Registered

2011-02-03

Start date

2010-02-28

Completion date

2020-12-31

Last updated

2023-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Melanoma

Keywords

melanoma, IL-2, Aldesleukin

Brief summary

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

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.

Interventions

DRUGIL-2

Observation only

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	Time frame
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
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026