Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer
Status:
Suspended
Trial end date:
2024-12-27
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 200 patients with melanoma. Researchers want
to know if TIL shrink s tumors in people with digestive tract, urothelial, breast, or
ovarian/endometrial cancers. 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 digestive tract, urothelial, breast, or ovarian/endometrial tumors to shrink and to see
if this treatment is safe.
Eligibility:
- Adults age 18-70 with upper or lower gastrointestinal, hepatobiliary, genitourinary,
breast, ovarian/endometrial cancer, or glioblastoma refractory to standard chemotherapy.
Design:
Work up stage: Patients will be seen as an outpatient at the 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.