CAR T Cell Receptor Immunotherapy Targeting EGFRvIII for Patients With Malignant Gliomas Expressing EGFRvIII
Status:
Completed
Trial end date:
2019-01-17
Target enrollment:
Participant gender:
Summary
Background:
The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for
treating patients with gliomas 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. In this protocol, we are
modifying the patient's white blood cells with a retrovirus that has the gene for epidermal
growth factor receptor (EGFR) vIII incorporated in the retrovirus.
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-EGFRvIII cells) are a safe and effective
treatment for advanced gliomas.
Eligibility:
- Adults age 18-70 with malignant glioma expressing the EGFRvIII molecule.
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-EGFRvIII 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-EGFRvIII 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 every month for the first year, and then every 1-2 months as long as
their tumors are shrinking. Follow up visits will take up to 2 days.