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

NCT01288963 | Completed DMC

• 1 other identifier: 09-333
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Melanoma

Keywords

melanoma; IL-2; Aldesleukin

Outcome Measures

Primary Outcomes (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 Outcomes (5)

• To validate the usefulness of serum fibronectin and VEGF levels as negative predictors of response

  2 years

• To explore the predictive value of several genetic polymorphisms associated with immune function

  2 years

• To explore the predictive value of BRAF^V600E mutational status as a predictor of response and benefit to high dose IL-2

  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

  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

  2 years

Study Arms (1)

IL-2 subjects

Subjects receiving IL-2 for advanced melanoma

Drug: IL-2

Interventions

IL-2 DRUG

Observation only

Also known as: aldesleukin

IL-2 subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects enrolled on DF/HCC Protocol 06-149

You may qualify if:

• 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

You may not qualify if:

• Prior immunotherapy for unresectable or metastatic disease
• Untreated brain metastases, leptomeningeal disease, or seizure disorder

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

tumor tissue, blood

MeSH Terms

Conditions

Melanoma

Interventions

Interleukin-2; aldesleukin

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• David McDermott, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2011
• First Posted: February 3, 2011
• Study Start: February 1, 2010
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

US (1)