Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Human Papillomavirus-Associated Cancers
Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
Participant gender:
Summary
Background:
The human papillomavirus (HPV) can cause a number of cancers, including cervical and throat
cancers. 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. Researchers want to know if TIL shrink s tumors in people
with human papilloma virus (HPV)-related cancer. 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 HPV-related cancers to shrink and to see if this treatment is safe.
Eligibility:
- Adults age 18-66 with HPV-related cancer 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 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.