T Cell Receptor Immunotherapy Targeting NY-ESO-1 for Patients With NY-ESO-1 Expressing Melanoma
Status:
Terminated
Trial end date:
2016-02-01
Target enrollment:
Participant gender:
Summary
Background:
The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for
treating patients with melanoma that involves taking white blood cells from the patient,
growing them in the laboratory in large numbers, genetically modifying them, and then giving
the cells back to the patient. In a previous study, the NCI Surgery Branch used the
anti-ESO-1 gene and a type of virus (retrovirus) to make these tumor-fighting cells
(anti-ESO-1 cells). About half of the patients who received this treatment experienced
shrinking of their tumors. In this study, we are using a slightly different method of
producing the anti-ESO-1 cells selected for a specific cell type, which we hope, will be
better in making the tumors shrink.
Objectives:
The purpose of this study is to see if these tumor fighting cells (genetically modified
cells) that express the receptor for the ESO-1 molecule on their surface can cause melanoma
tumors to shrink and to see if this treatment is safe.
Eligibility:
-Adults 18 and older with cancer that has the ESO-1 molecule on tumor surfaces
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 ESO-1 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-ESO 1 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.
Phase:
Phase 2
Details
Lead Sponsor:
National Cancer Institute (NCI)
Collaborator:
National Institutes of Health Clinical Center (CC)