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Clinical Trials associated with AKTi-treated TIL(NCI)A Phase I Trial for the Evaluation of the In Vivo Persistence of Adoptively-transferred Tumor-Infiltrating Lymphocytes Cultured With a Pharmacologic Inhibitor of AKT in Patients With Metastatic Melanoma
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.
100 Clinical Results associated with AKTi-treated TIL(NCI)
100 Translational Medicine associated with AKTi-treated TIL(NCI)
100 Patents (Medical) associated with AKTi-treated TIL(NCI)
100 Deals associated with AKTi-treated TIL(NCI)