Autologous SCT Followed by Dendritic Cell p53 Vaccination in Patients With Limited Stage Small Cell Lung Cancer

Phase II Trial of Autologous Peripheral Blood Hematopoietic Cell Transplantation (PBHCT) Followed by Dendritic Cell p53 Vaccination and Adoptive T Cell Transfer in Patients With Limited Stage Small Cell Lung Cancer

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%.

Inclusion Criteria:

• Histologically confirmed SCLC who presented with Limited Stage (LS) at diagnosis.
• Measurable disease at the time of initial therapy
• Appropriate treatment for LS-SCLC including radiotherapy and chemotherapy.
• Responsive disease to standard chemoradiation therapy as defined by RECIST
• Patients with CR after chemoradiation therapy are strongly recommended to be treated with prophylactic cranial irradiation
• CBC with an absolute neutrophil count (ANC) >/= 1,000/uL, hemoglobin >/= 8.0 g/DL and platelet count >/= 75,000/uL.
• Normal prothrombin time (PT) and partial thromboplastin time (aPTT), unless on monitored anticoagulation therapy for medical conditions not excluded in the trial.
• Liver enzymes: total bilirubin less than or equal to 2mg/dL; AST and ALT less than 1.5X the upper limit of normal.
• Creatinine clearance of >/= 60 mL/min
• Pulmonary: DLCO greater than 50%
• Cardiac: left ventricular ejection fraction greater than 45%

Exclusion Criteria:

• Patient with stable (SD) or progressive disease (PD) after 4 cycles of standard cisplatin and etoposide and concurrent chest irradiation
• Pregnant or lactating woman
• HIV infection confirmed by NAT
• Common variable immunodeficiency
• Active CNS malignancy
• Active bacterial, fungal or viral infection
• Unfavorable psychosocial evaluation or history of poor compliance to prescribed medical care
• Prior history of autologous or allogeneic hematopoietic cell transplantation
• Presence of protocol specific comorbid conditions