Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091039
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2004-09-07
Brief Title:
Vaccine Therapy Chemotherapy and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed With Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Pilot Trial of a CEATRICOM-Based Vaccine in Combination With Combined ChemotherapyRadiotherapy in Patients With Unresectable Stage III Non-Small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2005-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Vaccines made from a gene-modified virus may make the body build an immune response to kill tumor cells Drugs used in chemotherapy such as paclitaxel and carboplatin work in different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high energy x-rays to damage tumor cells Combining vaccine therapy with chemotherapy and radiation therapy may kill more tumor cells
PURPOSE This clinical trial is studying how well giving vaccine therapy together with paclitaxel carboplatin and radiation therapy works in treating patients with stage III non-small cell lung cancer that cannot be removed with surgery
PURPOSE This clinical trial is studying how well giving vaccine therapy together with paclitaxel carboplatin and radiation therapy works in treating patients with stage III non-small cell lung cancer that cannot be removed with surgery
Detailed Description:
OBJECTIVES
Primary
Determine the safety and feasibility of standard paclitaxel carboplatin and radiotherapy in combination with vaccinia-CEA-TRICOM vaccine fowlpox-CEA-TRICOM vaccine and recombinant fowlpox GM-CSF vaccine in patients with unresectable stage III non-small cell lung cancer
Secondary
Determine clinical response in patients treated with this regimen
Determine time to disease progression and overall median survival of patients treated with this regimen
Determine immunologic response in patients treated with this regimen
OUTLINE This is a pilot study
Vaccine Patients receive vaccinia-CEA-TRICOM vaccine subcutaneously SC on day 0 and fowlpox-CEA-TRICOM rF-CEA-TRICOM vaccine SC on days 14 29 43 57 70 91 and 112 Patients also receive recombinant fowlpox GM-CSF rF-GM-CSF vaccine SC with each vaccination Patients with stable or responding disease after day 112 continue to receive rF-CEA-TRICOM and rF-GM-CSF SC every 3 weeks in the absence of disease progression or unacceptable toxicity
Radiotherapy Patients undergo radiotherapy on days 21-25 28-32 35-39 42-46 49-53 56-60 and 63-67
Chemotherapy Concurrently with radiotherapy patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 21 28 35 42 49 56 and 63 Patients also receive paclitaxel and carboplatin on days 91 and 112 after completion of radiotherapy
Patients are followed annually for up to 15 years
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study within 4-6 months
Primary
Determine the safety and feasibility of standard paclitaxel carboplatin and radiotherapy in combination with vaccinia-CEA-TRICOM vaccine fowlpox-CEA-TRICOM vaccine and recombinant fowlpox GM-CSF vaccine in patients with unresectable stage III non-small cell lung cancer
Secondary
Determine clinical response in patients treated with this regimen
Determine time to disease progression and overall median survival of patients treated with this regimen
Determine immunologic response in patients treated with this regimen
OUTLINE This is a pilot study
Vaccine Patients receive vaccinia-CEA-TRICOM vaccine subcutaneously SC on day 0 and fowlpox-CEA-TRICOM rF-CEA-TRICOM vaccine SC on days 14 29 43 57 70 91 and 112 Patients also receive recombinant fowlpox GM-CSF rF-GM-CSF vaccine SC with each vaccination Patients with stable or responding disease after day 112 continue to receive rF-CEA-TRICOM and rF-GM-CSF SC every 3 weeks in the absence of disease progression or unacceptable toxicity
Radiotherapy Patients undergo radiotherapy on days 21-25 28-32 35-39 42-46 49-53 56-60 and 63-67
Chemotherapy Concurrently with radiotherapy patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 21 28 35 42 49 56 and 63 Patients also receive paclitaxel and carboplatin on days 91 and 112 after completion of radiotherapy
Patients are followed annually for up to 15 years
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study within 4-6 months
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 |
|---|---|---|---|
| NCI-6439 | None | None | None |
| NCI-04-C-0252 | None | None | None |