A Study Using Tumor-Reactive Autologous Tumor Infiltrating Lymphocytes (TIL) in Metastatic Melanomas

Phase 2

Terminated

• Conditions: Metastatic Melanoma

• Registration Number: NCT02375984
• Lead Sponsor: Saint John's Cancer Institute

Brief Summary

The purpose of this protocol is to determine whether autologous TIL infused in conjunction with systemic high-dose IL-2 after non-myeloablative chemotherapy with cyclophosphamide and fludarabine can cause consistent and durable objective responses in patients who have metastatic melanoma at the John Wayne Cancer Institute (JWCI).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-25
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-03
• Study Start: 2016-03-16
• Primary Completion: 2017-06-01
• Study Completion: 2017-06-01
• Status Verified: 2021-08
• Results First Submitted: 2021-08-03
• Results First Submitted QC: 2021-08-27
• Last Update Submitted: 2021-08-27
• Results First Posted: 2021-09-22
• Last Update Posted: 2021-09-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Clinical Response	12 weeks, or until development of new metastases or recurrence	At the end of 12 week follow up, the proportion of patients that showed clinical response (CR) determined by the disappearance of all target lesions, or partial response (PR) will be calculated. The patient is determined to have partial response as if 30% reduction in the sum of the longest diameter (SLD) of target lesions are shown from the baseline sum LD.

Secondary Outcome Measures

Name	Time	Method
Quality of Life	12 weeks, or until development of new metastases or recurrence	Quality of Life will be assessed and scored per European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) EORTC-QLQ-C30 version 3.0 requirements. The EORTC QLQ-C30 contains subscales for global health status, and physical, emotional, role, cognitive and social function with higher scores indicating better functioning (19). The change in QOL measured throughout the study period will be examined through mixed effect model adjusting for the baseline. Akaike information criteria (AIC) will be used to determine appropriate covariance structure.

Trial Locations

Locations (1)

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