Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006352
Status:
COMPLETED
Last Update Posted:
2012-07-18
First Post:
2000-10-04
Brief Title:
Monoclonal Antibody Therapy Plus BCG in Treating Patients With Limited-Stage Small Cell Lung Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
The SILVA Study Survival in an International Phase III Prospective Randomized LD Small Cell Lung Cancer Vaccination Study With Adjuvant BEC2 and BCG
Status:
COMPLETED
Status Verified Date:
2012-07
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 Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells BCG may activate the immune system to kill tumor cells Combining monoclonal antibody therapy with BCG may kill more tumor cells It is not yet known if monoclonal antibody therapy plus BCG is an effective treatment for limited-stage small cell lung cancer
PURPOSE Randomized phase III trial to determine the effectiveness of monoclonal antibody therapy plus BCG in treating patients who have limited-stage small cell lung cancer
PURPOSE Randomized phase III trial to determine the effectiveness of monoclonal antibody therapy plus BCG in treating patients who have limited-stage small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the impact of vaccination with adjuvant BCG and monoclonal antibody BEC2 on the survival of patients with limited stage small cell lung cancer
Determine the progression free survival in these patients after receiving this treatment regimen
Determine the safety of this treatment regimen in these patients
Assess the quality of life in these patients treated with this regimen
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center Karnofsky performance status 60-70 vs 80-100 and response to first line combined modality treatment complete remission vs partial remission Patients are randomized to one of two treatment arms
Arm I Patients receive vaccination with BCG and monoclonal antibody BEC2 intradermally on day 1 of weeks 0 2 4 6 and 10 in the absence of disease progression or unacceptable toxicity
Arm II Patients receive no further therapy Quality of life is assessed at baseline at weeks 6 12 and 24 and every 6 months thereafter until disease progression
Patients are followed at 6 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 570 patients 285 per treatment arm will be accrued for this study within 2 years
Determine the impact of vaccination with adjuvant BCG and monoclonal antibody BEC2 on the survival of patients with limited stage small cell lung cancer
Determine the progression free survival in these patients after receiving this treatment regimen
Determine the safety of this treatment regimen in these patients
Assess the quality of life in these patients treated with this regimen
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center Karnofsky performance status 60-70 vs 80-100 and response to first line combined modality treatment complete remission vs partial remission Patients are randomized to one of two treatment arms
Arm I Patients receive vaccination with BCG and monoclonal antibody BEC2 intradermally on day 1 of weeks 0 2 4 6 and 10 in the absence of disease progression or unacceptable toxicity
Arm II Patients receive no further therapy Quality of life is assessed at baseline at weeks 6 12 and 24 and every 6 months thereafter until disease progression
Patients are followed at 6 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 570 patients 285 per treatment arm will be accrued for this study within 2 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 |
|---|---|---|---|
| EORTC-08971B | None | None | None |