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Trial record 2 of 25 for:    SELECT | aldesleukin

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01288963
First Posted: February 3, 2011
Last Update Posted: August 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David F. McDermott, MD, Dana-Farber Cancer Institute
  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 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 David F. McDermott, MD, 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 ]

Secondary Outcome Measures:
  • 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 ]

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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01288963


Locations
United States, Massachusetts
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
  More Information

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
First Submitted: February 1, 2011
First Posted: February 3, 2011
Last Update Posted: August 30, 2016
Last Verified: August 2016

Keywords provided by David F. McDermott, MD, Dana-Farber Cancer Institute:
melanoma
IL-2
Aldesleukin

Additional relevant MeSH terms:
Aldesleukin
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interleukin-2
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents