Autologous SCT Followed by Dendritic Cell p53 Vaccination in Patients With Limited Stage Small Cell Lung Cancer
Primary Purpose
Small Cell Lung Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Small Cell Lung Cancer, SCLC, Limited Stage Small Cell Lung Cancer
Eligibility 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
Sites / Locations
- HLeeMoffitt
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
adeno virus vectored p53
Arm Description
Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes
Outcomes
Primary Outcome Measures
Number of Subjects Meeting 1-year Overall Survival
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
3 year progression-free survival (PFS) is defined as time from maximum response to relapse or progression of SCLC
Full Information
NCT ID
NCT00776295
First Posted
October 20, 2008
Last Updated
January 16, 2013
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00776295
Brief Title
Autologous SCT Followed by Dendritic Cell p53 Vaccination in Patients With Limited Stage Small Cell Lung Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Low accrual
Study Start Date
May 2007 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
Small Cell Lung Cancer, SCLC, Limited Stage Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
adeno virus vectored p53
Arm Type
Experimental
Arm Description
Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes
Intervention Type
Biological
Intervention Name(s)
Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Subjects Meeting 1-year Overall Survival
Description
Number of participants with overall survival from first day of cyclophosphamide and GM-CSF mobilization to the day of death
Time Frame
up to one year
Secondary Outcome Measure Information:
Title
3 Year Progression-free Survival
Description
3 year progression-free survival (PFS) is defined as time from maximum response to relapse or progression of SCLC
Time Frame
up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Kharfan-Dabaja, MD
Organizational Affiliation
H. Lee Moffitt Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
HLeeMoffitt
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.moffitt.org/
Description
H. Lee Moffitt Cancer Center & Research Institute
Learn more about this trial
Autologous SCT Followed by Dendritic Cell p53 Vaccination in Patients With Limited Stage Small Cell Lung Cancer
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