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Brief Title: Phase I/II Study to Assess the Safety and Activity of Enhanced TCR Transduced Autologous T Cells in Metastatic Melanoma
Official Title: Phase I/II Study to Assess the Safety and Activity of Enhanced TCR Transduced Autologous T Cells in Metastatic Melanoma
Study ID: NCT01350401
Brief Summary: The purpose of this early (phase I/II) clinical trial is to assess the effects (both good and bad) of genetically modified T cells after chemotherapy on your cancer and general health.
Detailed Description: Purpose of this study is to evaluate the safety and tolerability of autologous genetically modified T cells. Genetic material is transferred into the subject's previously harvested autologous T cells to redirect them to target melanoma cells rather than their usual target. Study subjects must have histologically or cytologically melanoma stage 3/4 and their tumor must express HLA Class 1 allele HLA-A\*0201 for NY-ESO-1/LAGE. Subjects must also have measureable disease on study entry, as defined by at least one lesion that can be measured in at least one dimension \>= 10mm with spiral CT scan.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Yale School of Medicine, New Haven, Connecticut, United States
Washington University in St. Louis, Saint Louis, Missouri, United States
Name: Gerald P Linette, MD, PhD
Affiliation: Washington University School of Medicine
Role: PRINCIPAL_INVESTIGATOR
Name: Harriet Kluger, MD
Affiliation: Yale New Haven Hospital
Role: PRINCIPAL_INVESTIGATOR