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

Beth Israel Lahey Health

Status: Completed

Conditions: Malignant Melanoma

Treatments: Drug: IL-2

Study type: Observational

Funder types: Other

Identifiers

NCT01288963

09-333

Details and patient eligibility

About

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.

Full 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.

Enrollment: 153 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

153 participants in 1 patient group

IL-2 subjects

Description:

Subjects receiving IL-2 for advanced melanoma

Treatment:

Drug: IL-2