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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
David F. McDermott, MD, Dana-Farber Cancer Institute Identifier:
First received: February 1, 2011
Last updated: August 29, 2016
Last verified: August 2016
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
Drug: IL-2

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 Study Completion Date: February 2018
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
IL-2 subjects
Subjects receiving IL-2 for advanced melanoma
Drug: IL-2
Observation only
Other Name: aldesleukin

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects enrolled on DF/HCC Protocol 06-149

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 identifier: NCT01288963

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

Responsible Party: David F. McDermott, MD, Principal Investigator, Dana-Farber Cancer Institute Identifier: NCT01288963     History of Changes
Other Study ID Numbers: 09-333 
Study First Received: February 1, 2011
Last Updated: August 29, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs processed this record on October 26, 2016