Trial record 2 of 74 for:    IL-2 SELECT

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01288963
Recruitment Status : Active, not recruiting
First Posted : February 3, 2011
Last Update Posted : February 1, 2018
Information provided by (Responsible Party):
David F. McDermott, MD, Dana-Farber Cancer Institute

February 1, 2011
February 3, 2011
February 1, 2018
February 2010
June 2019   (Final data collection date for primary outcome 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 [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT01288963 on Archive Site
  • To validate the usefulness of serum fibronectin and VEGF levels as negative predictors of response [ Time Frame: 2 years ]
  • To explore the predictive value of several genetic polymorphisms associated with immune function [ Time Frame: 2 years ]
  • To explore the predictive value of BRAF^V600E mutational status as a predictor of response and benefit to high dose IL-2 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 2 years ]
Same as current
Not Provided
Not Provided
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
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.
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.
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
tumor tissue, blood
Non-Probability Sample
Subjects enrolled on DF/HCC Protocol 06-149
Malignant Melanoma
Drug: IL-2
Observation only
Other Name: aldesleukin
IL-2 subjects
Subjects receiving IL-2 for advanced melanoma
Intervention: Drug: IL-2
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Same as current
February 2020
June 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
David F. McDermott, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Not Provided
Principal Investigator: David McDermott, MD Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
January 2018