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
- 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%
- 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
- Prior history of autologous or allogeneic hematopoietic cell transplantation
- Presence of protocol specific comorbid conditions