Clinical Trial VICCMEL1081
Title
The High-Dose Aldesleukin (IL-2) "Select" Trial: A Prospective Tissue Collection Protocol to Investigate Predictive Models of Response to High Dose IL-2 Treatment in Patients with Advanced Melanoma
Principal Investigator(s)
Details
- Protocol No. VICCMEL1081
- Open Date: 09/28/2011
- Staging: NA
- Age Group: Adults
- Scope: National
- Objective: 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 therapy (Class 2) than the historical 16% response rate in an unselected patient population
- Disease Sites: Melanoma
- Therapies: Correlative
- Drugs: Interleukin (IL-2, Aldesleukin)
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01288963
- Secondary Protocol No: Not Specified
Description
The purpose of this study is to see which people with melanoma have a better response to IL-2 and to identify markers that may tell us who will respond to treatment with IL-2 by collecting information ( for example cancer diagnosis and history, prior treatments for cancer etc), blood and tumor samples prior to treatment and tumor measurements after treatment.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
|---|---|
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
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