Expired Study
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Tampa, Florida 33612


Purpose:

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%.


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


NCT ID:

NCT00776295


Primary Contact:

Principal Investigator
Mohamed Kharfan-Dabaja, MD
H. Lee Moffitt Cancer Center


Backup Contact:

N/A


Location Contact:

Tampa, Florida 33612
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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