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

NCT ID: NCT01288963

Last Updated: 2023-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

153 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Malignant Melanoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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IL-2 subjects

Subjects receiving IL-2 for advanced melanoma

IL-2

Intervention Type DRUG

Observation only

Interventions

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IL-2

Observation only

Intervention Type DRUG

Other Intervention Names

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aldesleukin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dana-Farber Cancer Institute

OTHER

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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David McDermott

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David McDermott, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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09-333

Identifier Type: -

Identifier Source: org_study_id

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