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

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ClinicalTrials.gov Identifier: NCT01288963
Recruitment Status : Active, not recruiting
First Posted : February 3, 2011
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
David F. McDermott, MD, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date February 1, 2011
First Posted Date February 3, 2011
Last Update Posted Date February 12, 2019
Study Start Date February 2010
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 2, 2011)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01288963 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 2, 2011)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
tumor tissue, blood
Sampling Method Non-Probability Sample
Study Population Subjects enrolled on DF/HCC Protocol 06-149
Condition Malignant Melanoma
Intervention Drug: IL-2
Observation only
Other Name: aldesleukin
Study Groups/Cohorts IL-2 subjects
Subjects receiving IL-2 for advanced melanoma
Intervention: Drug: IL-2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: February 2, 2011)
153
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2020
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01288963
Other Study ID Numbers 09-333
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party David F. McDermott, MD, Dana-Farber Cancer Institute
Study Sponsor Dana-Farber Cancer Institute
Collaborators Not Provided
Investigators
Principal Investigator: David McDermott, MD Beth Israel Deaconess Medical Center
PRS Account Dana-Farber Cancer Institute
Verification Date February 2019