In Vivo Persistence of Adoptively-Transferred TIL Cultured With Akti in People With Metastatic Melanoma

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 \<TAB\>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 \<TAB\>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.

Timeline

Start

2015-06-24

Primary completion

2016-06-29

Completion

2016-06-29

Publications

• Background Rosenberg SA, Yang JC, Sherry RM, Kammula US, Hughes MS, Phan GQ, Citrin DE, Restifo NP, Robbins PF, Wunderlich JR, Morton KE, Laurencot CM, Steinberg SM, White DE, Dudley ME. Durable complete responses in heavily pretreated patients with metastatic melanoma using T-cell transfer immunotherapy. Clin Cancer Res. 2011 Jul 1;17(13):4550-7. doi: 10.1158/1078-0432.CCR-11-0116. Epub 2011 Apr 15.
• Background Robbins PF, Morgan RA, Feldman SA, Yang JC, Sherry RM, Dudley ME, Wunderlich JR, Nahvi AV, Helman LJ, Mackall CL, Kammula US, Hughes MS, Restifo NP, Raffeld M, Lee CC, Levy CL, Li YF, El-Gamil M, Schwarz SL, Laurencot C, Rosenberg SA. Tumor regression in patients with metastatic synovial cell sarcoma and melanoma using genetically engineered lymphocytes reactive with NY-ESO-1. J Clin Oncol. 2011 Mar 1;29(7):917-24. doi: 10.1200/JCO.2010.32.2537. Epub 2011 Jan 31.
• Background Tran E, Turcotte S, Gros A, Robbins PF, Lu YC, Dudley ME, Wunderlich JR, Somerville RP, Hogan K, Hinrichs CS, Parkhurst MR, Yang JC, Rosenberg SA. Cancer immunotherapy based on mutation-specific CD4+ T cells in a patient with epithelial cancer. Science. 2014 May 9;344(6184):641-5. doi: 10.1126/science.1251102.

Drugs

Indications