Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049218
Status:
COMPLETED
Last Update Posted:
2014-05-09
First Post:
2002-11-12
Brief Title:
Chemotherapy Followed By Vaccine Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase I-II Trial Using Dendritic Cells Transduced With An Adenoviral Vector Containing The p53 Gene To Immunize Patients With Extensive Stage Small Cell Lung Cancer After Standard Chemotherapy
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Vaccines made from a gene-modified virus may make the body build an immune response to kill tumor cells Combining vaccine therapy with chemotherapy may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of chemotherapy followed by adenovirus p53 vaccine therapy in treating patients who have extensive-stage small cell lung cancer
PURPOSE Phase III trial to study the effectiveness of chemotherapy followed by adenovirus p53 vaccine therapy in treating patients who have extensive-stage small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of autologous dendritic cell-adenovirus p53 vaccine administered after standard chemotherapy in patients with extensive stage small cell lung cancer
Determine the toxicity of this regimen in these patients
Determine the development of an anti-p53-specific immune response in these patients after treatment with this regimen
Determine the tumor response rate time to progression and overall survival of patients treated with this regimen
Determine the frequency of anti-adenovirus immune responses in these patients after treatment with this regimen
OUTLINE This is a dose-escalation study of autologous dendritic cell-adenovirus p53 vaccine
Patients undergo leukapheresis and dendritic cells are cultured Adenovirus carrying p53 gene particles are added to the dendritic cells to make the vaccine Leukapheresis is performed before chemotherapy or 8 weeks after the last dose of chemotherapy if the patient has already started chemotherapy
Patients receive standard chemotherapy before receiving the vaccine The recommended regimen is carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1-3 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients with progressive disease PD at 6 weeks after chemotherapy are removed from the study
Patients are followed at day 140 and then every 3 months thereafter
PROJECTED ACCRUAL A total of 43-58 patients 3-18 for phase I and 40 for phase II will be accrued for this study within 3 years
Determine the maximum tolerated dose of autologous dendritic cell-adenovirus p53 vaccine administered after standard chemotherapy in patients with extensive stage small cell lung cancer
Determine the toxicity of this regimen in these patients
Determine the development of an anti-p53-specific immune response in these patients after treatment with this regimen
Determine the tumor response rate time to progression and overall survival of patients treated with this regimen
Determine the frequency of anti-adenovirus immune responses in these patients after treatment with this regimen
OUTLINE This is a dose-escalation study of autologous dendritic cell-adenovirus p53 vaccine
Patients undergo leukapheresis and dendritic cells are cultured Adenovirus carrying p53 gene particles are added to the dendritic cells to make the vaccine Leukapheresis is performed before chemotherapy or 8 weeks after the last dose of chemotherapy if the patient has already started chemotherapy
Patients receive standard chemotherapy before receiving the vaccine The recommended regimen is carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1-3 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients with progressive disease PD at 6 weeks after chemotherapy are removed from the study
Patients are followed at day 140 and then every 3 months thereafter
PROJECTED ACCRUAL A total of 43-58 patients 3-18 for phase I and 40 for phase II will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 0205-538 | OTHER | OBA | None |