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
  Purpose

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 Intervention
Malignant Melanoma
Other: Observation

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

tumor tissue, blood


Estimated Enrollment: 153
Study Start Date: February 2010
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
IL-2 subjects
Subjects receiving IL-2 for advanced melanoma
Other: Observation
Observation only

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects enrolled on DF/HCC Protocol 06-149

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288963

Contacts
Contact: David McDermott, MD 617-632-9250 dmcdermo@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: David McDermott, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: David McDermott, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: David F. McDermott, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01288963     History of Changes
Other Study ID Numbers: 09-333
Study First Received: February 1, 2011
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
melanoma
IL-2
Aldesleukin

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on September 18, 2014