Small Cell Lung Cancer
Conditions
Keywords
Small Cell Lung Cancer, SCLC, 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%.
Interventions
BIOLOGICALCombined 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
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Meeting 1-year Overall Survival | 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
| Measure | Time frame | Description |
|---|---|---|
| 3 Year Progression-free Survival | up to 3 years | 3 year progression-free survival (PFS) is defined as time from maximum response to relapse or progression of SCLC |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| p53 Vaccination Dendritic cell p53 vaccination | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | p53 Vaccination |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
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
Time frame: up to one year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| p53 Vaccination | Number of Subjects Meeting 1-year Overall Survival | 2 participants |
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
Time frame: up to 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| p53 Vaccination | 3 Year Progression-free Survival | 0 participants |