Immunotherapy Using 41BB Selected Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma
Status:
Terminated
Trial end date:
2016-07-21
Target enrollment:
Participant gender:
Summary
Background:
The National Cancer Institute (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 100
patients. In this study, we are selecting a specific subset of white blood cells from the
tumor that we think are the most effective in fighting tumors and will use only these cells
in making the tumor fighting cells.
Objective:
The purpose of this study is to see if these specifically selected tumor fighting cells can
cause melanoma tumors to shrink and to see if this treatment is safe.
Eligibility:
- Adults age 18-70 with metastatic melanoma who have a tumor that can be safely removed.
Design:
- Work up stage: Patients will be seen as an outpatient at the National Institutes of
Health (NIH) clinical Center and undergo a history and physical examination, scans,
x-rays, lab tests, and other tests as needed
- Surgery: If the patients meet all of the requirements for the study they will undergo
surgery to remove a tumor that can be used to grow the TIL product.
- Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood
cells. {Leukapheresis is a common procedure, which removes only the white blood cells
from the patient.}
- Treatment: Once their cells have grown, the patients will be admitted to the hospital
for the conditioning chemotherapy, the tumor infiltrating lymphocytes (TIL) cells and
aldesleukin. 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.
...