Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Melanoma
Status:
Terminated
Trial end date:
2013-08-01
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 with
aldesleukin (IL-2) a drug that keeps the white blood cells active. These cells are
called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment
to over 200 patients with melanoma.
- This study will use chemotherapy to prepare the immune system before this white blood
cell treatment. Our prior studies indicate that aldesleukin may not be required for cell
transfer.
Objectives:
- To see if chemotherapy and white blood cell therapy without aldesleukin is a safe and
effective treatment for metastatic melanoma.
Eligibility:
- Individuals at least 18 years of age and less than or equal to 70 years of age with
metastatic melanoma.
Design:
- Work up stage: Patients will be seen as an outpatient at the National Institute 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 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 will take up
to 2 days.