CAR T Cell Receptor Immunotherapy Targeting Mesothelin for Patients With Metastatic Cancer
Status:
Terminated
Trial end date:
2018-12-17
Target enrollment:
Participant gender:
Summary
Background:
The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for
treating patients with metastatic 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. In this
protocol, we are modifying the patients white blood cells with a retrovirus that has the gene
for anti-mesothelin 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 tumor fighting cells (anti-mesothelin cells) cause metastatic cancer tumors to
shrink.
Eligibility:
- Adults age 18-70 with metastatic cancer expressing the mesothelin 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-mesothelin 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-mesothelin 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.