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| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IL-2 subjects | Subjects receiving IL-2 for advanced melanoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IL-2 | Drug | Observation only |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects enrolled on DF/HCC Protocol 06-149
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| Name | Affiliation | Role |
|---|---|---|
| David McDermott, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D007376 | Interleukin-2 |
| C082598 | aldesleukin |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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tumor tissue, blood
| 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 |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |