Procure Tumor and Initiate Melanoma Tumor-Reactive Tumor Infiltration

Procure Tumor and Initiate Melanoma Tumor-Reactive Tumor Infiltration Lymphocytes (TIL)

Study Overview

• Status: Terminated
• Conditions: Melanoma

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 Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • John Wayne Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

cancer clinic

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate Feasibility of conducting TIL procurement in a single-site setting	Cell viability, viable number and TIL potency using standardized methods	5 years
Evaluate Safety of conducting TIL procurement in a single-site setting	lab personnel training during procurement, isolation, testing tumor reactivity and cryopreservation	5 separate TIL procedures

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Saint John's Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): June 4, 2018
• Study Completion (Actual): June 4, 2018

Study Registration Dates

• First Submitted: January 13, 2015
• First Submitted That Met QC Criteria: January 13, 2015
• First Posted (Estimate): January 16, 2015

Study Record Updates

• Last Update Posted (Actual): February 21, 2019
• Last Update Submitted That Met QC Criteria: February 19, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: TIL-PROCURE-0614

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No