The purpose of this study is to determine whether p53 vaccination followed by high dose chemotherapy and autologous HCT and T cell therapy significantly induces immune responses resulting in 1-year survival greater that the current 70%.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Autologous Dendritic Cells Derived from Peripheral Blood Mononuclear Cells, Cultured with Granulocyte-Macrophage Colony-Stimulating Factor and Interleukin 4, Transfected with Adenovirus Vector (Ad5CMV-p53, Introgen Therapeutics) Expressing Wildtype p53 Gene; Combined with Autologous Expanded T Lymphocytes (CD3+, CD4+, and CD8+), Cultured with OKT3 (Orthoclone) and Anti-CD28 (Repligen) Coated Magnetic Beads
HLeeMoffitt
Tampa, Florida, United States
Number of Subjects Meeting 1-year Overall Survival
Number of participants with overall survival from first day of cyclophosphamide and GM-CSF mobilization to the day of death
Time frame: up to one year
3 Year Progression-free Survival
3 year progression-free survival (PFS) is defined as time from maximum response to relapse or progression of SCLC
Time frame: up to 3 years
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