Protocol Number: 08-C-0155
This study tests an experimental gene therapy cancer treatment that uses the patient's own lymphocytes (type of white blood cell), which are specially selected and genetically modified with a gene called anti-p53 T-cell receptor to target and destroy their tumor. Dendritic cells containing the p53 gene are also given as a vaccine. Objectives: To test the safety of the above treatment and determine if it can cause the patient's tumor to shrink. Eligibility: Patients 18 years of age and older whose cancer has spread beyond the original site and does not respond to standard treatment. Patients with tissue type HLA-A*0201. Patients whose cancer cells express the p53 gene. Design:
Workup: Patients have scans, x-rays, laboratory tests, other tests as needed and leukapheresis, a procedure for collecting white cells to modify in the laboratory and later reinfuse into the patient. Chemotherapy (days -7 to -1): Patients have chemotherapy for 1 week to prepare the immune system to receive the treated lymphocytes. Cell infusion, vaccination and IL-2 treatment (day 0 for 1 to 5 days): Patients receive the anti-p53-T cell receptor containing lymphocytes by a 30-minute infusion through a vein. Starting within 24 hours of the cell infusion, they receive high-dose IL-2 infusions every 8 hours for a maximum 15 doses. Vaccination (days 0, 7, 14 and 28): Patients receive p53-containing dendritic cells as a vaccine injected under the skin in the upper arm or thigh. Recovery: Patients rest for 1 to 2 weeks to recover from the effects of treatment. Tumor biopsy: Patients may undergo a biopsy (surgical removal of a small piece of tumor) after treatment to look at the effects of treatment on the immune cells in the tumor. Follow-up: Patients return to the clinic 4 - 6 weeks after completing their regimen for a third set of vaccines and an evaluation. They then return for evaluations with a physical examination, review of side effects, laboratory tests and scans once a month for several months. They may have leukapheresis at some visits to allow researches to look at the effect of treatment on the immune system and check the viability of the infused cells. Patients whose tumor appears to be shrinking return every month for several more months. Those whose tumor is growing are referred to another study or back to their local physician. All patients return to NIH for a physical examination once a year for 5 years and then complete a follow-up questionnaire or telephone interview for another 10 years.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/30/2009
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