In Vivo Persistence of Adoptively-Transferred TIL Cultured With Akti in People With Metastatic Melanoma
Status:
Withdrawn
Trial end date:
2016-06-29
Target enrollment:
Participant gender:
Summary
Background:
- One cancer therapy involves taking white blood cells from a person, changing them in a lab,
and then giving the cells back to the person. These cells are called tumor infiltrating
lymphocytes (TIL). Researchers want to grow some of the TIL cells with the drug Akti to see
if they live longer than those grown without it.
Objectives:
- To see if TIL cells grown with Akti live longer than those grown without it.
Eligibility:
- Adults 18 70 with metastatic melanoma
Design:
- Participants will:
- Be screened with tests including scans, x-rays, heart and lung tests, blood and urine
tests, and a possible colonoscopy.
- Have tumor surgery or biopsy.
- Have a large catheter inserted into a vein in the upper chest.
- Receive leukapheresis for 4 5 hours. Blood is removed through a needle in an arm. White
blood cells are removed. The rest of the blood is returned by needle in the other
arm.
- The cells will be changed in a laboratory.
- Participants will check into the hospital and:
- For 5 days, get 1 2 chemotherapy drugs by catheter.
- For 1 3 days, get the changed cells by catheter.
- For several days, get 2 drugs to stimulate cells, one by injection, the other by
catheter.
- For 7 12 days, recover in the hospital.
- After treatment, participants will:
- Take an antibiotic and antiviral for at least 6 months.
- Return to NIH for several 2-day visits for a few years. At each visit, participants will
have lab tests, imaging studies, and a physical exam. At some visits, they may have
leukapheresis or blood tests.