Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma
Status:
Active, not recruiting
Trial end date:
2029-09-28
Target enrollment:
Participant gender:
Summary
Background:
- The NCI Surgery Branch has developed an experimental therapy that involves taking white
blood cells from patients' tumors, growing them in the laboratory in large numbers, and
then giving the cells back to the patient. These cells are called Tumor Infiltrating
Lymphocytes, or TIL and we have given this type of treatment to over 400 patients with
melanoma.
- In this trial, we are determining if there is a difference in the response between
patients who have received prior anti-PD1 treatment to those who have not received this
prior ant-PD1 treatment.
Objectives:
- To determine if there is a difference in the rate of response between patients who have
received prior anti-PD1 and those who have not.
Eligibility:
- Individuals at least 18 years and less than or equal to 70 years of age who have metastatic
melanoma.
Design:
- Work up stage: Participants will be screened with a physical exam and medical history.
Blood and urine samples will be collected.
- Surgery: Surgery or biopsy will be performed to obtain tumor from which to grow white
blood cells. White blood cells will be grown from the tumor in the laboratory.
- Leukapheresis: Participants will have leukapheresis to collect additional white blood
cells. (Leukapheresis is a common procedure which removes only the white blood cells
from the patient.)
- Treatment: Participants will receive standard dose chemotherapy to prepare their immune
system to accept the white blood cells. Participants will receive an infusion of their
own white blood cells grown from tumor. They will also receive aldesleukin for up to
five days to boost the immune system s response to the white blood cells. They will stay
in the hospital for about 4 weeks for the treatment.
- Follow up: Patients will return to the clinic for a physical exam, review of side
effects, lab tests, and scans about every 1-3 months for the first year, and then every
6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2
days.