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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Dana-Farber Cancer Institute
Sponsor:
Information provided by (Responsible Party):
David F. McDermott, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01288963
First received: February 1, 2011
Last updated: February 3, 2014
Last verified: February 2014

February 1, 2011
February 3, 2014
February 2010
February 2016   (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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01288963 on ClinicalTrials.gov Archive Site
  • To validate the usefulness of serum fibronectin and VEGF levels as negative predictors of response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To explore the predictive value of several genetic polymorphisms associated with immune function [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
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
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

tumor tissue, blood

Non-Probability Sample

Subjects enrolled on DF/HCC Protocol 06-149

Malignant Melanoma
Other: Observation
Observation only
IL-2 subjects
Subjects receiving IL-2 for advanced melanoma
Intervention: Other: Observation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
153
Not Provided
February 2016   (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
Both
18 Years and older
No
Contact: David McDermott, MD 617-632-9250 dmcdermo@bidmc.harvard.edu
United States
 
NCT01288963
09-333
Yes
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
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP