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

Stopped early · Phase 2

Conditions studied: Small Cell Lung Cancer

In brief

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%.

Key facts

Study ID

NCT00776295

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

2

Starts

2007-05-01

Expected to finish

2010-08-01

Last updated by the study team

2013-01-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• HLeeMoffitt — Tampa, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.