Cell Therapy for Metastatic Melanoma Using CD8 Enriched Tumor Infiltrating Lymphocytes
Status:
Terminated
Trial end date:
2015-03-01
Target enrollment:
Participant gender:
Summary
Background:
- One experimental treatment for certain types of cancer is cell therapy, which involves
collecting lymphocytes (white blood cells) from a tumor, growing them in the laboratory in
large numbers, and then modifying the cells with a gene (interleukin-12 (IL-12)) that
stimulates the immune system to attack and destroy the cancer cells. Because this treatment
is experimental, researchers are interested in determining the side effects and overall
effectiveness of cell therapy using white blood cells modified with IL-12 as a treatment for
aggressive cancer.
Objectives:
- To determine the safety and effectiveness of cell therapy using IL-12 modified tumor white
blood cells to treat metastatic melanoma.
Eligibility:
- Individuals greater than or equal to 18 years of age and less than or equal to age 66 who
have been diagnosed with metastatic melanoma.
Design:
- Participants will be screened with a medical history, physical examination, blood and
urine tests, and imaging studies.
- Cells for treatment will be collected during tumor biopsy or surgery.
- Prior to the start of cell therapy, participants will have imaging procedures, heart and
lung function tests, and blood and urine tests, as well as leukapheresis to collect
additional white blood cells.
- For 5 days before the cell infusion, participants will be admitted for inpatient
chemotherapy with cyclophosphamide and fludarabine to suppress the immune system in
preparation for the cell therapy.
- Participants will receive the modified white blood cells as an infusion 1 to 4 days
after the last dose of chemotherapy. The day after the infusion, participants will
receive filgrastim to stimulate blood cell growth.
- Participants will remain as inpatients for at least 5 to 10 days to recover from the
treatment, and will be followed regularly after the treatment to study side effects and
general effectiveness.
- Participants who initially respond to treatment but have a relapse may have one
additional treatment using the same procedure.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institutes of Health Clinical Center (CC)