Procure Tumor and Initiate Melanoma Tumor-Reactive Tumor Infiltration

Melanoma Clinical Trial

Official title:

Procure Tumor and Initiate Melanoma Tumor-Reactive Tumor Infiltration

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02339987
• Other study ID #: TIL-PROCURE-0614
• Status: Terminated
• Start date: November 2014
• Est. completion date: June 4, 2018

Study information

• Verified date: February 2019
• Source: John Wayne Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: June 4, 2018
• Est. primary completion date: June 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Locations

Country	Name	City	State
United States	John Wayne Cancer Institute	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
John Wayne Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate Feasibility of conducting TIL procurement in a single-site setting	Cell viability, viable number and TIL potency using standardized methods	5 years
Primary	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	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