Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00776295
Recruitment Status : Terminated (Low accrual)
First Posted : October 21, 2008
Results First Posted : June 21, 2012
Last Update Posted : January 24, 2013
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Tracking Information
First Submitted Date  ICMJE October 20, 2008
First Posted Date  ICMJE October 21, 2008
Results First Submitted Date  ICMJE October 4, 2011
Results First Posted Date  ICMJE June 21, 2012
Last Update Posted Date January 24, 2013
Study Start Date  ICMJE May 2007
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2012)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 20, 2008)
1-year survival from the first day of cyclophosphamide and GM-CSF mobilization to the day of death. [ Time Frame: 1 & 2 months after transplant, every 6 months up to 5 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2012)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2008)
  • p53 immunity measured by ELISPOT for interferon-y producing cells, and by p53-specific tetramer in HLA-A *0201 patients [ Time Frame: Laboratory study ]
  • Tumor response/progression rates (CR, PR, PD, SD) in patients with measurable disease, as defined by RECIST criteria [ Time Frame: 6 months, 1 year, 2 year, 3 year and 5 years from day of mobilization chemotherapy ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous SCT Followed by Dendritic Cell p53 Vaccination in Patients With Limited Stage Small Cell Lung Cancer
Official Title  ICMJE 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
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 survival greater that the current 70%.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Small Cell Lung Cancer
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: adeno virus vectored p53
Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes
Intervention: Biological: Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 18, 2012)
2
Original Estimated Enrollment  ICMJE
 (submitted: October 20, 2008)
53
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00776295
Other Study ID Numbers  ICMJE MCC 14955
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lee Moffitt Cancer Center and Research Institute
Study Sponsor  ICMJE H. Lee Moffitt Cancer Center and Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mohamed Kharfan-Dabaja, MD H. Lee Moffitt Cancer Center
PRS Account H. Lee Moffitt Cancer Center and Research Institute
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP