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

Sponsor
Dana-Farber Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01288963
Collaborator
(none)
153
Enrollment
1
Location
130
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Actual Enrollment :
153 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
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
Actual Study Start Date :
Feb 1, 2010
Actual Primary Completion Date :
Dec 1, 2020
Actual Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
IL-2 subjects

Subjects receiving IL-2 for advanced melanoma

Drug: IL-2
Observation only
Other Names:
  • aldesleukin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. To validate the usefulness of serum fibronectin and VEGF levels as negative predictors of response [2 years]

    2. To explore the predictive value of several genetic polymorphisms associated with immune function [2 years]

    3. To explore the predictive value of BRAF^V600E mutational status as a predictor of response and benefit to high dose IL-2 [2 years]

    4. 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]

    5. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215

    Sponsors and Collaborators

    • Dana-Farber Cancer Institute

    Investigators

    • Principal Investigator: David McDermott, MD, Beth Israel Deaconess Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    David F. McDermott, MD, Principal Investigator, Dana-Farber Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT01288963
    Other Study ID Numbers:
    • 09-333
    First Posted:
    Feb 3, 2011
    Last Update Posted:
    Jan 14, 2021
    Last Verified:
    Jan 1, 2021
    Keywords provided by David F. McDermott, MD, Principal Investigator, Dana-Farber Cancer Institute
    melanoma
    IL-2
    Aldesleukin
    Additional relevant MeSH terms:
    Melanoma
    Aldesleukin

    Study Results

    No Results Posted as of Jan 14, 2021