Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Ocular Melanoma
Status:
Terminated
Trial end date:
2017-05-31
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 200
patients with melanoma. This study will use chemotherapy to prepare the immune system before
this white blood cell treatment. After receiving the cells, the drug aldesleukin (IL-2) may
be given to help the cells stay alive longer.
Objectives:
- To see if chemotherapy and white blood cell therapy is a safe and effective treatment for
advanced ocular melanoma.
Eligibility:
- Individuals at least greater than or equal to 16 years to less than or equal to 75 years
who have advanced ocular melanoma.
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 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.