T Cell Receptor Immunotherapy Targeting HPV-16 E6 for HPV-Associated Cancers
Status:
Completed
Trial end date:
2016-06-28
Target enrollment:
Participant gender:
Summary
Background:
The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for
treating patients with cancer that involves taking white blood cells from the patient,
growing them in the laboratory in large numbers, genetically modifying these specific cells
with a type of virus (retrovirus) to attack only the tumor cells, and then giving the cells
back to the patient. This type of therapy is called gene transfer. Researchers want to test
this on human papilloma virus (HPV)-associated cancers.
Objective:
- The purpose of this study is to determine a safe number of these cells to infuse and to see
if these particular tumor-fighting cells (Anti-HPV E6) can shrink tumors associated with HPV
and test the toxicity of this treatment.
Eligibility:
- Adults age 18-66 with an HPV-16-associated cancer.
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
- Leukapheresis: If the patients meet all of the requirements for the study they will
undergo leukapheresis to obtain white blood cells to make the anti HPV E6 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 anti HPV E6 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.