Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104780
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
2005-03-03
Brief Title:
Vaccine Therapy in Treating Patients With Stage IIIB Stage IV or Recurrent Non-Small Cell Lung Cancer
Sponsor:
Epimmune
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Open Label Multi-center Study of EP2101 Therapeutic Vaccine in Patients With Stage IIIB Stage IV or Recurrent Non-Small Cell Lung Cancer NSCLC
Status:
UNKNOWN
Status Verified Date:
2006-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Vaccines made from peptides may make the body build an effective immune response to kill tumor cells
PURPOSE This phase II trial is studying how well vaccine therapy works in treating patients with stage IIIB stage IV or recurrent non-small cell lung cancer
PURPOSE This phase II trial is studying how well vaccine therapy works in treating patients with stage IIIB stage IV or recurrent non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Compare the overall survival of patients with HLA-A2-positive stage IIIB or IV or recurrent non-small cell lung cancer NSCLC treated with vaccine therapy comprising EP-2101 emulsified in montanide ISA-51 with that of historical controls and patients with HLA-A2-negative stage IIIB or IV or recurrent NSCLC who undergo observation only
Determine the safety of this vaccine in these patients
Secondary
Determine progression-free survival of patients treated with this vaccine
Determine the frequency magnitude and breadth of cytotoxic and helper T-cell response to vaccine epitopes in patients treated with this vaccine
OUTLINE This is an open-label multicenter study Patients are assigned to 1 of 2 treatment groups according to HLA-A2 status
Group I HLA-A2 positive Patients receive vaccine therapy comprising EP-2101 emulsified in montanide ISA-51 subcutaneously once in weeks 0 3 6 9 12 and 15
Group II HLA-A2 negative Patients undergo observation in weeks 9 and 18 After completion of study treatment patients in group I are followed at 3 weeks All patients are then followed at months 1 2 3 5 and 8 every 3 months for 2 years and then annually for 2 years
PROJECTED ACCRUAL A total of 84 patients will be accrued for this study within 1 year
Primary
Compare the overall survival of patients with HLA-A2-positive stage IIIB or IV or recurrent non-small cell lung cancer NSCLC treated with vaccine therapy comprising EP-2101 emulsified in montanide ISA-51 with that of historical controls and patients with HLA-A2-negative stage IIIB or IV or recurrent NSCLC who undergo observation only
Determine the safety of this vaccine in these patients
Secondary
Determine progression-free survival of patients treated with this vaccine
Determine the frequency magnitude and breadth of cytotoxic and helper T-cell response to vaccine epitopes in patients treated with this vaccine
OUTLINE This is an open-label multicenter study Patients are assigned to 1 of 2 treatment groups according to HLA-A2 status
Group I HLA-A2 positive Patients receive vaccine therapy comprising EP-2101 emulsified in montanide ISA-51 subcutaneously once in weeks 0 3 6 9 12 and 15
Group II HLA-A2 negative Patients undergo observation in weeks 9 and 18 After completion of study treatment patients in group I are followed at 3 weeks All patients are then followed at months 1 2 3 5 and 8 every 3 months for 2 years and then annually for 2 years
PROJECTED ACCRUAL A total of 84 patients will be accrued for this study within 1 year
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EPIMMUNE-EP2101-201 | None | None | None |
| MCMRC-0461 | None | None | None |