At a glance
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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
In Brief
A Phase 1 clinical trial evaluating AKTi-treated TIL, Cyclophosphamide, and 2 other interventions for Metastatic Melanoma. Withdrawn before enrollment.
Signals
Detailed 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.
Study Details
Timeline
Interventions
On day 0, cells will be infused intravenously (IV) over 20-30 minutes (between 1 and 4 days after the last dose of fludarabine).
Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days.
Patients will receive Fludarabine 25 mg/m2/day for 5 days.
Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).