Status:
TERMINATED
Autologous SCT Followed by Dendritic Cell p53 Vaccination in Patients With Limited Stage Small Cell Lung Cancer
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 su...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00776295
Start Date
May 1 2007
End Date
August 1 2010
Last Update
January 24 2013
Active Locations (1)
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1
HLeeMoffitt
Tampa, Florida, United States, 33612