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

Phase 2

Terminated

Interventions: Biological: Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes

Brief Summary: 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%.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
adeno virus vectored p53	Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes	Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes

Primary Outcome Measures

Name	Time	Method
Number of Subjects Meeting 1-year Overall Survival	up to one year	Number of participants with overall survival from first day of cyclophosphamide and GM-CSF mobilization to the day of death

Secondary Outcome Measures

Name	Time	Method
3 Year Progression-free Survival	up to 3 years	3 year progression-free survival (PFS) is defined as time from maximum response to relapse or progression of SCLC