Procure Tumor and Initiate Melanoma Tumor-Reactive Tumor Infiltration

Terminated

• Conditions: Melanoma

• Registration Number: NCT02339987
• Lead Sponsor: Saint John's Cancer Institute

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-01-13
• Study First Submitted QC: 2015-01-13
• Study First Posted: 2015-01-16
• Primary Completion: 2018-06-04
• Study Completion: 2018-06-04
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-19
• Last Update Posted: 2019-02-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

John Wayne Cancer Institute; 🇺🇸 Santa Monica, California, United States