IL-2 "SELECT" Tissue Collection Protocol in Patients With Advanced Melanoma
- Registration Number
- NCT01288963
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 153
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description IL-2 subjects IL-2 Subjects receiving IL-2 for advanced melanoma
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method To validate the usefulness of serum fibronectin and VEGF levels as negative predictors of 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 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 predictive value of several genetic polymorphisms associated with immune function 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
Trial Locations
- Locations (1)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States