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Low accrual
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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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adeno virus vectored p53 | Experimental | Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expanded T-lymphocytes | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| 3 Year Progression-free Survival | 3 year progression-free survival (PFS) is defined as time from maximum response to relapse or progression of SCLC | up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Kharfan-Dabaja, MD | H. Lee Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HLeeMoffitt | Tampa | Florida | 33612 | United States |
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| Label | URL |
|---|---|
| H. Lee Moffitt Cancer Center \& Research Institute | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | p53 Vaccination | Dendritic cell p53 vaccination |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | p53 Vaccination | Dendritic cell p53 vaccination |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | participants | up to one year |
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| Secondary | 3 Year Progression-free Survival | 3 year progression-free survival (PFS) is defined as time from maximum response to relapse or progression of SCLC | Posted | Number | participants | up to 3 years |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Biological/Vaccine | Combined adenovirus vectored p53 tranfected dedritic cell vaccine and ex vivo expaned T-lymphocytes | 0 | 2 | 0 | 2 |
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Early termination of trial due to small number of subjects thus leading to unreliabe data
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Kharfan Dabaja, MD | H. Lee Moffitt Cancer Center | 961-1350000 | 5350 | MK143@aub.edu.lb |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| >=65 years |
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