Melanoma
Conditions
Brief summary
Procure Tumor and Initiate Melanoma Tumor-Reactive Tumor Infiltration Lymphocytes (TIL)
Detailed description
The purpose of this study is to allow the collection of tissue from subjects to be used in future research studies by scientists and to isolate tumor fighting cells for the future treatment of Melanoma.
Interventions
None listed
Sponsors
Saint John's Cancer Institute
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients must have metastatic melanoma with a resectable metastasis who are undergoing resection for palliation, therapeutic or curative purpose. 2. Patients must be \> 15 years of age and must have metastatic melanoma. 3. Patients must meet standard pre-operative requirements as determined by the surgeon to be candidates for surgery. 4. Patients must be able to understand and sign the Informed Consent document. 5. Patients must be able to complete the supplemental data form
Exclusion criteria
1. women who are pregnant or breastfeeding 2. inability to give consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate Feasibility of conducting TIL procurement in a single-site setting | 5 years | Cell viability, viable number and TIL potency using standardized methods |
| Evaluate Safety of conducting TIL procurement in a single-site setting | 5 separate TIL procedures | lab personnel training during procurement, isolation, testing tumor reactivity and cryopreservation |
Secondary
| Measure | Time frame |
|---|---|
| To determine whether TIL Procurement, isolation, testing tumor reactivity and cryopreservation can be performed at John Wayne Cancer Institute (JWCI) and Providence Saint John's Health Center (PSJHC) and infused into patients | 5 years |
Countries
United States
Outcome results
None listed