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:
H. Lee Moffitt Cancer Center and Research Institute
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00776295
First received: October 20, 2008
Last updated: January 16, 2013
Last verified: January 2013
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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: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided
| 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 |
| Study First Received: | October 20, 2008 |
| Results First Received: | October 4, 2011 |
| Last Updated: | January 16, 2013 |
| Health Authority: | United States: Food and Drug Administration |
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 |
ClinicalTrials.gov processed this record on May 16, 2013