Autologous SCT Followed by Dendritic Cell p53 Vaccination in Patients With Limited Stage Small Cell Lung Cancer
Condition: Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes
Intervention description: 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Small Cell Lung Cancer; SCLC; Limited Stage Small Cell Lung Cancer

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%.
    

Eligibility criteria:

        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