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

This study has been terminated.
(Low accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00776295
First Posted: October 21, 2008
Last Update Posted: January 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
  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%.

Condition Intervention Phase
Small Cell Lung Cancer Biological: Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Autologous Peripheral Blood Hematopoietic Cell Transplantation (PBHCT) Followed by Dendritic Cell p53 Vaccination and Adoptive T Cell Transfer in Patients With Limited Stage Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Number of Subjects Meeting 1-year Overall Survival [ Time Frame: 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:
  • 3 Year Progression-free Survival [ Time Frame: up to 3 years ]
    3 year progression-free survival (PFS) is defined as time from maximum response to relapse or progression of SCLC


Enrollment: 2
Study Start Date: May 2007
Study Completion Date: August 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: adeno virus vectored p53
Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes
Biological: Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776295


Locations
United States, Florida
HLeeMoffitt
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Principal Investigator: Mohamed Kharfan-Dabaja, MD H. Lee Moffitt Cancer Center
  More Information

Additional Information:
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00776295     History of Changes
Obsolete Identifiers: NCT00609583
Other Study ID Numbers: MCC 14955
First Submitted: October 20, 2008
First Posted: October 21, 2008
Results First Submitted: October 4, 2011
Results First Posted: June 21, 2012
Last Update Posted: January 24, 2013
Last Verified: January 2013

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Small Cell Lung Cancer
SCLC
Limited Stage Small Cell Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Vaccines
Immunologic Factors
Physiological Effects of Drugs