T Cell Receptor Immunotherapy Targeting MAGE-A3 for Patients With Metastatic Cancer Who Are HLA-A*01 Positive
Status:
Terminated
Trial end date:
2018-09-10
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. In this protocol, we are
modifying the patients white blood cells with a retrovirus that has the gene for anti-MAGE-A3
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-MAGE A3 cells) cause tumors to shrink and to
be certain the treatment is safe
Eligibility:
- Adults age 18-66 with cancer expressing the MAGE-A3 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 MAGE-A3 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 MAGE-A3 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.