Clinical trial NCT01288963: IL-2 "SELECT" Tissue Collection Protocol in Patients With Advanced Melanoma
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Melanoma
Keywords: melanoma
IL-2
Aldesleukin
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
First posted: 2011-02-03
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects enrolled on DF/HCC Protocol 06-149

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 2 years
Secondary outcomes:
measure: To validate the usefulness of serum fibronectin and VEGF levels as negative predictors of response
timeFrame: 2 years
measure: To explore the predictive value of several genetic polymorphisms associated with immune function
timeFrame: 2 years
measure: To explore the predictive value of BRAF^V600E mutational status as a predictor of response and benefit to high dose IL-2
timeFrame: 2 years
measure: 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
timeFrame: 2 years
measure: 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
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: David McDermott, MD
role: PRINCIPAL_INVESTIGATOR
References: