This study is planned to test the safety and tolerability of the TIL regimen. The study will also test how well TIL fights cancer. The study will enroll children, teenagers, and young adults with solid tumors that have returned or are not responding to treatment for whom no effective standard-of-care treatment options exist. Study details include: * The study will last up to 2 years after the TIL infusion (Day 0) for each person. * The treatment will last up to 10 days for each person. * Study visits will be every 2 weeks until Day 42, every 6 weeks until Month 6, and every 3 months until Year 2.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes.
Children's Hospital of Colorado
Aurora, Colorado, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
Rutgers Cancer Institute
New Brunswick, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Incidence rate of Treatment-Emergent Adverse Events
To evaluate the safety and tolerability of the TIL regimen that occurs from the start of TIL infusion and up to 30 days after TIL infusion per CTCAE.
Time frame: Up to 24 months
Objective Response Rate
To evaluate the proportion of participants who have confirmed complete response (CR) or partial response (PR) per RECIST v1.1 or RAPNO.
Time frame: Up to 24 months
Duration of Response
To measure the time that criteria are met for complete response (CR) or partial response (PR) per RECIST v1.1 or RAPNO.
Time frame: Up to 24 months
Disease Control Rate
To measure by the percentage of participants with best overall confirmed response of complete response (CR) or partial response (PR) at any time or stable disease (SD) for at least 4 weeks per RECIST v1.1 or RAPNO.
Time frame: Up to 24 months
Progression-Free Survival
To evaluate the time from the date of the TIL infusion until disease progression per RECIST v1.1 or RAPNO.
Time frame: Up to 24 months
Overall Survival
To measure the time from the date of TIL infusion to death due to any cause.
Time frame: Up to 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.